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1.  Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase 3 Double-Blind, Randomized Trial from the North Central Cancer Treatment Group N06C4 
A 2-arm, double-blinded, randomized trial to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy.
Methods and Materials
Patients with ductal carcinoma in situ or invasive breast carcinoma receiving external beam radiotherapy to breast or chest wall were randomly assigned to daily apply 0.1% MMF or placebo cream. Primary study end point was provider-assessed maximum grade of Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation dermatitis. Secondary end points included provider-assessed CTCAE grade 3 or greater radiation dermatitis and adverse-event monitoring. Patient-reported outcome (PRO) measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and quality of life self-assessment. Assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy.
In total, 176 patients were enrolled from September 21, 2007 through December 7, 2007. The provider-assessed primary end point showed no difference in mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs 1.3 for placebo; P=.18). CTCAE toxicity was greater in placebo group (P=.04), primarily from pruritus. For PRO measures, the maximum Skindex-16 score for MMF group showed less itching (P=.008), less irritation (P=.01), less symptom persistence or recurrence (P=.02), and less annoyance with skin problems (P=.04); the group's maximum Skin Toxicity Assessment Tool score showed less burning sensation (P=.02) and less itching (P=.002).
Patients receiving daily MMF during radiotherapy may experience reduced acute skin toxicity in comparison to placebo.
PMCID: PMC2995007  PMID: 20800381
breast neoplasms; mometasone furoate; radiotherapy; skin manifestations; toxicity
2.  The Effect of Sterilization Methods on the Physical Properties of Silk Sericin Scaffolds 
AAPS PharmSciTech  2011;12(2):771-781.
Protein-based biomaterials respond differently to sterilization methods. Since protein is a complex structure, heat, or irradiation may result in the loss of its physical or biological properties. Recent investigations have shown that sericin, a degumming silk protein, can be successfully formed into a 3-D scaffolds after mixing with other polymers which can be applied in skin tissue engineering. The objective of this study was to investigate the effectiveness of ethanol, ethylene oxide (EtO) and gamma irradiation on the sterilization of sericin scaffolds. The influence of these sterilization methods on the physical properties such as pore size, scaffold dimensions, swelling and mechanical properties, as well as the amount of sericin released from sericin/polyvinyl alcohol/glycerin scaffolds, were also investigated. Ethanol treatment was ineffective for sericin scaffold sterilization whereas gamma irradiation was the most effective technique for scaffold sterilization. Moreover, ethanol also caused significant changes in pore size resulting from shrinkage of the scaffold. Gamma-irradiated samples exhibited the highest swelling property, but they also lost the greatest amount of weight after immersion for 24 h compared with scaffolds obtained from other sterilization methods. The results of the maximum stress test and Young’s modulus showed that gamma-irradiated and ethanol-treated scaffolds are more flexible than the EtO-treated and untreated scaffolds. The amount of sericin released, which was related to its collagen promoting effect, was highest from the gamma-irradiated scaffold. The results of this study indicate that gamma irradiation should have the greatest potential for sterilizing sericin scaffolds for skin tissue engineering.
PMCID: PMC3134674  PMID: 21671201
ethanol; ethylene oxide; gamma irradiation; scaffold; sericin
3.  Efficacy and Safety of Terbinafine Hydrochloride 1% Cream vs. Sertaconazole Nitrate 2% Cream in Tinea Corporis and Tinea Cruris: A Comparative Therapeutic Trial 
Indian Journal of Dermatology  2013;58(6):457-460.
To the best of our knowledge, till date no study comparing the efficacy and safety of terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream has been done in localized tinea corporis and tinea cruris.
This clinical trial was carried out to study and compare the efficacy of topical terbinafine hydrochloride 1% cream and sertaconazole nitrate 2% cream in localized tinea corporis and tinea cruris and to know the adverse effects of these antifungal creams.
Settings and Design:
In this prospective, single blind, randomized control trial with two arms, patient were randomized into two groups Group A (treatment with terbinafine cream) and Group B (treatment with sertaconazole cream). A total of 38 patients were enrolled for the study, 20 patients in group A and 18 patients in group B. But five patients of group A and three patients of group B were lost for follow-ups. Therefore sample size was of 30 patients with 15 patients in group A and group B each.
Materials and Methods:
Patients in group A and B were treated with twice daily topical 1% terbinafine hydrochloride and 2% sertaconazole nitrate cream respectively for a total duration of three weeks. Clinical improvement in signs and symptoms of each clinical parameter, namely itching, erythema, papules, pustules, vesicles, and scaling were graded weekly and clinical cure was assessed. KOH mount and culture was done weekly up to 3 weeks to access mycological cure. Fungal culture was done on Sabouraud's dextrose agar with chloramphenicol and cycloheximide.
Statistical Analysis Used:
Statistical analysis was done using students paired and unpaired t-tests from the data obtained.
Comparison between Group A and Group B for complete cure (clinical and mycological) showed that at the end of 3 weeks both terbinafine and sertaconazole groups had 100% complete cure. When the two groups were compared for complete cure, at the end of 1st and 2nd week, statistically non-significant results were observed (P = 0.461 and P = 0.679 respectively). However, at the end of 2nd week, complete cure rate for terbinafine was 80% as compared to 73.35% for sertaconazole with no statistical significance. In both Group A and Group B, clinically significant local side effects like erythema, swelling, stinging sensation, or increased itching were not noticed. A majority of our patients in both the group showed Trichophyton rubrum followed by Trichophyton mentagrophytes growth on culture. In Group A, 11 patients showed growth of T. rubrum, 2 patients showed growth of T. mentagrophytes, and 1 patient had only KOH test positive. In Group B, 10 patients revealed growth of T. rubrum, followed by growth of T. mentagrophytes in 3 and Microsporum canis in 2 patients. The therapeutic response is more or less same in infection with different species.
The newer fungistatic drug sertaconazole nitrate 2% cream was as effective as terbinafine hydrochloride 1% cream which is one of the fungicidal drugs, though terbinafine hydrochloride 1% cream has higher rates of complete cure at the end of 2 weeks as compared to sertaconazole nitrate 2% cream. Both the drugs showed good tolerability with no adverse effects.
PMCID: PMC3827518  PMID: 24249898
Dermatophytosis; sertaconazole nitrate 2% cream; terbinafine hydrochloride 1% cream
4.  Daily Application of Fluocinonide 0.1% Cream for the Treatment of Atopic Dermatitis 
Objective: To assess the efficacy and safety of topical fluocinonide 0.1% cream for the treatment of atopic dermatitis. Design: In this double-blind, vehicle-controlled study, patients were randomized to receive treatment with fluocinonide 0.1% cream applied once (n=109) or twice daily (n=102) or vehicle applied once (n=50) or twice daily (n=52) for two weeks. Setting: Multicenter, outpatient. Participants: Patients aged 18 years or older with atopic dermatitis affecting at least two percent but less than 10 percent of body surface area. Measurements: Efficacy and safety measures included lesion severity, pruritus, hypothalamic-pituitary-adrenal axis suppression, and adverse events. Results: Fluocinonide 0.1% cream applied once or twice daily was more effective than cream vehicle. Both regimens were similarly efficacious after two weeks of treatment. At the end of treatment, lesions were cleared or almost cleared in 59 percent of subjects treated once daily and 57 percent of subjects treated twice daily with fluocinonide 0.1% cream. Further, considerable residual benefit remained after cessation of twice-daily versus once-daily treatment. Skin safety evaluations showed no significant adverse effects of treatment on signs or symptoms of skin atrophy. Fluocinonide 0.1% cream and vehicle treatments did not differ significantly in their suppression of the hypothalamic-pituitary-adrenal axis, nor did hypothalamic-pituitary-adrenal axis suppression differ significantly following once- or twice-daily treatment with fluocinonide 0.1% cream. Fluocinonide 0.1% cream was well tolerated. Conclusion: Once- or twice-daily topical application of fluocinonide 0.1% cream for 14 days was safe and effective for treating atopic dermatitis in this adult patient population. The efficacy of once-daily application was comparable to twice-daily application.
PMCID: PMC2923967  PMID: 20729956
5.  Itch in psoriasis: epidemiology, clinical aspects and treatment options 
Pruritus is an important symptom in psoriasis vulgaris, may be severe and seriously affect the quality of life of patients, but published data on its frequency and characteristics are limited.
The study objective was to characterize the prevalence of itch in psoriatic patients and the effect of treatment modalities by using a comprehensive itch questionnaire of own design.
A structured itch questionnaire was given to 90 patients with moderate to severe chronic-plaque psoriasis selected consecutively from the patients visiting the Department of Dermatology of the University of Florence. The questionnaire concerned the areas involved psoriasis and pruritus, the pruritus characteristics, the worsening and relieving factors and treatment modalities. Itch intensity was reflected by a 10 point visual analog scale (VAS) and the degree of symptoms discriminated between mild (1–3), moderate (4–7) and severe (8–10).
Almost 85% of psoriatic patients suffered from itching; the frequency of pruritus was daily and mean intensity by VAS scale was moderate. Presence and intensity of pruritus and body mass index (BMI) were correlated. 40% of patients with pruritus were overweight (BMI > 25 < 30) and 10% obese (BMI > 30). Almost all patients appeared unsatisfied with the available treatment modalities for pruritus in psoriasis. Emollients, topical steroids and calcipotriol cream could relieve pruritus but their effect was temporary. Among the antipsoriatic therapies, phototherapy with narrow band ultraviolet B (nb-UVB) was the most effective treatment in reducing pruritus. Biological therapies, mainly etanercept and efalizumab, proved useful in its control.
The questionnaire was a useful tool to characterize itch, and the results might help us to better understand pruritus in psoriasis. The results confirmed the need for a global study of psoriasis with regard to both the cutaneous manifestations and the itch symptom.
PMCID: PMC3047933  PMID: 21436964
itch; psoriasis; pruritus; epidemiology; phototherapy; etanercept; efalizumab
6.  Preliminary Characterization of Genipin-Cross-Linked Silk Sericin/Poly(vinyl alcohol) Films as Two-Dimensional Wound Dressings for the Healing of Superficial Wounds 
BioMed Research International  2013;2013:904314.
The genipin-cross-linked silk sericin/poly(vinyl alcohol) (PVA) films were developed aiming to be applied as two-dimensional wound dressings for the treatment of superficial wounds. The effects of genipin cross-linking concentration on the physical and biological properties of the films were investigated. The genipin-cross-linked silk sericin/PVA films showed the increased surface density, tensile strength, and percentage of elongation, but decreased percentage of light transmission, water vapor transmission rate, and water swelling, compared to the non-cross-linked films. This explained that the cross-linking bonds between genipin and silk sericin would reduce the mobility of molecular chains within the films, resulting in the more rigid molecular structure. Silk sericin was released from the genipin-cross-linked films in a sustained manner. In addition, either L929 mouse fibroblast or HaCat keratinocyte cells showed high percentage of viability when cultured on the silk sericin/PVA films cross-linked with 0.075 and 0.1% w/v genipin. The in vivo safety test performed according to ISO 10993-6 confirmed that the genipin-cross-linked silk sericin/PVA films were safe for the medical usages. The efficacy of the films for the treatment of superficial skin wounds will be further investigated in vivo and clinically. The genipin-cross-linked silk sericin/PVA films would be promising choices of two-dimensional wound dressings for the treatment of superficial wounds.
PMCID: PMC3784068  PMID: 24106722
7.  A double-blind randomised controlled trial of a natural oil-based emulsion (Moogoo Udder Cream®) containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer 
Radiation-induced skin reaction (RISR) is one of the most common and distressing side effects of radiotherapy in patients with cancer. It is featured with swelling, redness, itching, pain, breaks in skin, discomfort, and a burning sensation. There is a lack of convincing evidence supporting any single practice in the prevention or management of RISR.
This double-blinded randomised controlled trial aims to investigate the effects of a natural oil-based emulsion containing allantoin (as known as Moogoo Udder Cream®) versus aqueous cream in reducing RISR, improving pain, itching and quality of life in this patient group. One group will receive Moogoo Udder Cream®. Another group will receive aqueous cream. Outcome measures will be collected using patient self-administered questionnaire, interviewer administered questionnaire and clinician assessment at commencement of radiotherapy, weekly during radiotherapy, and four weeks after the completion of radiotherapy.
Despite advances of radiologic advances and supportive care, RISR are still not well managed. There is a lack of efficacious interventions in managing RISR. While anecdotal evidence suggests that Moogoo Udder Cream® may be effective in managing RISR, research is needed to substantiate this claim. This paper presents the design of a double blind randomised controlled trial that will evaluate the effects of Moogoo Udder Cream® versus aqueous cream for managing in RISR in patients with cancer.
Trial registration
ACTRN 12612000568819
PMCID: PMC3419129  PMID: 22849762
8.  Effects of a novel formulation of fluocinonide 0.1% cream on skin barrier function in atopic dermatitis 
To determine the effect of a novel formulation of fluocinonide cream on skin barrier function in subjects with atopic dermatitis.
The authors performed an open-label, investigator-blinded, side-by-side, controlled trial examining skin barrier function before and after a two-week course of a class I, super-potent topical steroid.
Outpatient university-based dermatology clinic in Portland, Oregon.
Twenty-five subjects aged 12 or older with a diagnosis of moderate, severe, or very severe AD were recruited for this study.
Fluocinonide 0.1% cream, a novel formulation of a class I super-potent topical steroid, was applied to all affected areas, except a control site, once daily tor two weeks or until clear. The control target site was treated with the vehicle once daily.
Main Outcome Measure(s)
The study’s primary outcome was change in skin barrier function as measured by basal transepidermal water loss (TEWL) in acute lesional skin from baseline as measured at two weeks.
TEWL readings significantly decreased (reflecting improved barrier function) in both the active and control target sites. The active target site decreased 14.35 ± 16 mg/cm2 per hour; 95 percent confidence interval, P<0.001. The control target site decreased 8.75 ± 11.80 mg/cm2 per hour in 25 subjects; 95 per cent confidence interval, P<0.001. Skin electrical capacitance also improved significantly, reflecting improved stratum corneum hydration with therapy. Pruritus, clinical severity, and quality of life scores all showed significant improvement by the end of the study.
The authors have shown that short-term treatment with a novel formulation of 0.1% fluocinonide led to significantly improved barrier function as measured by basal TEWL in subjects with active moderate to severe AD. These data suggest short-term treatment with AD with a super-potent corticosteroid improves skin barrier function.
PMCID: PMC3156681  PMID: 21283922
9.  Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia 
BMC Anesthesiology  2011;11:25.
Post-herpetic neuralgia (PHN) is a common type of neuropathic pain that can severely affect quality of life. NGX-4010, a capsaicin 8% dermal patch, is a localized treatment that can provide patients with significant pain relief for up to 3 months following a single 60-minute application. The NGX-4010 application can be associated with application-site pain and in previous clinical trials pretreatment with a topical 4% lidocaine anesthetic was used to enhance tolerability. The aim of the current investigation was to evaluate tolerability of NGX-4010 after pretreatment with lidocaine 2.5%/prilocaine 2.5% anesthetic cream.
Twenty-four patients with PHN were pretreated with lidocaine 2.5%/prilocaine 2.5% cream for 60 minutes before receiving a single 60-minute application of NGX-4010. Tolerability was assessed by measuring patch application duration, the proportion of patients completing over 90% of the intended treatment duration, application site-related pain using the Numeric Pain Rating Scale (NPRS), and analgesic medication use to relieve such pain. Safety was assessed by monitoring adverse events (AEs) and dermal irritation using dermal assessment scores.
The mean treatment duration of NGX-4010 was 60.2 minutes and all patients completed over 90% of the intended patch application duration. Pain during application was transient. A maximum mean change in NPRS score of +3.0 was observed at 55 minutes post-patch application; pain scores gradually declined to near pre-anesthetic levels (+0.71) within 85 minutes of patch removal. Half of the patients received analgesic medication on the day of treatment; by Day 7, no patients required medication. The most common AEs were application site-related pain, erythema, edema, and pruritus. All patients experienced mild dermal irritation 5 minutes after patch removal, which subsequently decreased; at Day 7, no irritation was evident. The maximum recorded dermal assessment score was 2.
NGX-4010 was well tolerated following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with PHN. The tolerability of the patch application appeared comparable with that seen in other studies that used 4% lidocaine cream as the pretreatment anesthetic. This study is registered at as number NCT00916942.
PMCID: PMC3292968  PMID: 22182397
10.  Skin Equivalent Tissue-Engineered Construct: Co-Cultured Fibroblasts/ Keratinocytes on 3D Matrices of Sericin Hope Cocoons 
PLoS ONE  2013;8(9):e74779.
The development of effective and alternative tissue-engineered skin replacements to autografts, allografts and xenografts has became a clinical requirement due to the problems related to source of donor tissue and the perceived risk of disease transmission. In the present study 3D tissue engineered construct of sericin is developed using co-culture of keratinocytes on the upper surface of the fabricated matrices and with fibroblasts on lower surface. Sericin is obtained from “Sericin Hope” silkworm of Bombyx mori mutant and is extracted from cocoons by autoclave. Porous sericin matrices are prepared by freeze dried method using genipin as crosslinker. The matrices are characterized biochemically and biophysically. The cell proliferation and viability of co-cultured fibroblasts and keratinocytes on matrices for at least 28 days are observed by live/dead assay, Alamar blue assay, and by dual fluorescent staining. The growth of the fibroblasts and keratinocytes in co-culture is correlated with the expression level of TGF-β, b-FGF and IL-8 in the cultured supernatants by enzyme-linked immunosorbent assay. The histological analysis further demonstrates a multi-layered stratified epidermal layer of uninhibited keratinocytes in co-cultured constructs. Presence of involucrin, collagen IV and the fibroblast surface protein in immuno-histochemical stained sections of co-cultured matrices indicates the significance of paracrine signaling between keratinocytes and fibroblasts in the expression of extracellular matrix protein for dermal repair. No significant amount of pro inflammatory cytokines (TNF-α, IL-1β and nitric oxide) production are evidenced when macrophages grown on the sericin matrices. The results all together depict the potentiality of sericin 3D matrices as skin equivalent tissue engineered construct in wound repair.
PMCID: PMC3772899  PMID: 24058626
11.  Effect of aromatherapy on pruritus relief in hemodialysis patients 
Pruritus is one of the commonest problems in patients with end-stage renal failure undergoing hemodialysis. Pruritus is an irritating symptom which can directly affect the life quality of patients with chronic renal failure. However, available treatments have failed to relieve the symptom and kidney transplant remains the definite treatment of the problem. A recently proposed treatment for pruritus is the use of complementary medicine. Thus, the aim of this research is to study the effect of aromatherapy on pruritus relief in hemodialysis patients.
The study is a pre- and post-clinical trial, carried out in dialysis centers of Isfahan University of Medical Sciences in 2009. Sample was performed using convenient sampling method and the participants were selected from among the patient who received hemodialysis three times a week for 3-5 hours and had pruritus scores above 3. All the participants received seven minutes of hand massage in the non-fistulated hand with 3-5 ml of lavender, mint, and tea tree oils at 5% concentration for six sessions (two weeks). The data of the study were analyzed using descriptive and inferential statistics by SPSS software, version 16.
Twenty patients with end-stage renal failure who had pruritus fulfilled the course of the study. Data analysis indicated that aromatherapy significantly relieved pruritus (p < 0.05).
Aromatherapy can significantly relieve pruritus in hemodialysis patients.
PMCID: PMC3203284  PMID: 22049288
Aromatherapy; pruritus; hemodialysis
12.  Sericin, a protein derived from silkworms, accelerates the proliferation of several mammalian cell lines including a hybridoma 
Cytotechnology  2002;40(1-3):3-12.
Sericin, a constituent of the silkworm cocoon, was added to the culture of four mammalian cell lines: murine hybridoma 2E3-O,human hepatoblastoma HepG2, human epithelial HeLa and human embryonal kidney 293 cells. The proliferation of all cell lineswas accelerated in the presence of sericin. The hybridoma cellline was further studied. The 2E3-O cell line was so well adapted to serum-free medium that both the proliferation rate and maximum cell density in serum-free ASF103 medium were higher than in RPMI medium supplemented with all lots of FBS tested, and this proliferation was stimulated by the addition of sericin in a dose-dependent manner. Stimulation was observed at sericin concentrations from 0.01 to 0.1 %, although 1% sericin was severely harmful to the culture. In comparison with bovine serum albumin (BSA), a widely used supplement in serum-free medium, sericin had an equivalent effect on the proliferation of the hybridomas and sericin additively stimulated the proliferation with BSA. Although heat easily denatures and inactivates most proteins, the activity of sericin was not affected by autoclaving. In a similar manner to the silkworm-derived sericin, recombinant sericin synthesized in E. coli also stimulated the hybridoma proliferation, irrespective of whether it was autoclaved or filtered. Since BSA is obtained from bovine serum and the risk of infections such as bovine spongiform encephalopathy cannot be eradicated, sericin derived from insects could be a preferable culture medium supplement for stimulating the proliferation of mammalian cells.
PMCID: PMC3449532  PMID: 19003099
HeLa; HepG2; hybridoma; proliferation; sericin; serum-free medium
13.  Pimecrolimus Cream 1% in the Management of Atopic Dermatitis in Pediatric Patients: A Meta-Analysis 
PLoS ONE  2014;9(4):e93095.
To evaluate the efficacy and safety of pimecrolimus cream 1% in the treatment of AD in the pediatric population.
PubMed, EMBASE, Web of Science and Cochrane library databases were searched till July 2013. The randomized and nonrandomized blinded studies of pimecrolimus cream 1% applied twice daily with Jaded score ≥3 in pediatric patients with AD were included. The efficacy outcomes included investigator global assessment (IGA), eczema area and severity index (EASI) scores, pruritus and care giver's assessments and flares free period. Adverse events were reviewed to assess the safety.
Out of 81 studies, 7 were selected that enrolled 2,170 pediatric patients. The pooled analysis reported that pimecrolimus was no better to vehicle reducing eczema at day-8, day-26 and six weeks (OR 4.95, 95% CI 2.79–8.80), (OR 9.69, 95% CI 4.12–22.83) and (OR 3.83. 95% CI 1.94–7.56), respectively in children. Similarly, pimecrolimus did not show beneficial effects when analyzed for mild or absent pruritus at day 4 (OR 8.29, 95% CI 3.88–17.72 favoring vehicle), day 43 (OR 1.81 95% CI 1.13–2.89 favoring vehicle) and 1 week (OR 2.29, 95%CI 1.45 to 3.60 favoring vehicle) as compared with vehicle. One study comparing pimecrolimus with tacrolimus found no significant difference in achieving mild or absent pruritus (OR 0.94, 95% CI 0.44–1.99). More patients showed an improvement in overall disease in vehicle group at day 8 (OR 3.30, 95% CI 2.03–5.35), day 29 (OR 14.14, 95% CI 6.87–29.13) and day 43 (OR 4.11, 95% CI 2.59–6.52) as compared with pimecrolimus 1% group, as assessed by caregivers. No significant difference was seen between the total AEs in both groups (pimecrolimus vs vehicle/tacrolimus) (OR 1.19, 95% CI 0.85, 1.65)
The results of the present meta-analysis showed that pimecrolimus cream 1% was not significantly better to vehicle for AD in pediatrics population.
PMCID: PMC3972203  PMID: 24691404
14.  Comparative Assessment of the Efficacy and Safety of Sertaconazole (2%) Cream Versus Terbinafine Cream (1%) Versus Luliconazole (1%) Cream In Patients with Dermatophytoses: A Pilot Study 
Indian Journal of Dermatology  2013;58(1):34-38.
Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses.
Aims and Objectives:
To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses.
Materials and Methods:
83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial ‘Treatment Phase’ involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a ‘Follow-up Phase’ at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse.
Of the 83 patients, 62 completed the study, sertaconazole (n = 20), terbinafine (n = 22) and luliconazole (n = 20). The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85%) showed resolution of pruritus as compared to terbinafine (54.6%); and luliconazole (70%), (P < 0.05 sertaconazole vs terbinafine). There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in sertaconazole group (97.1%) as compared to terbinafine (91.2%) and luliconazole (92.9%). All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis.
Sertaconazole was better than terbinafine and luliconazole in relieving signs and symptoms during study and follow up period. At the end of ‘Treatment Phase’ and ‘Follow-up’ Phase, all patients showed negative mycological assessment in all three treatment groups suggesting no recurrence of the disease.
PMCID: PMC3555370  PMID: 23372210
Dermatophytoses; luliconazole; sertaconazole; terbinafine; tinea corporis; tinea cruris
15.  Clinical and instrumental assessment of the effects of a new product based on hydroxypropyl chitosan and potassium azeloyl diglycinate in the management of rosacea 
Rosacea is a chronic inflammatory skin disease affecting mostly facial skin. Its origin is multifactorial. Important steps in its treatment are avoidance of any triggering factor and control of skin inflammation.
To assess the benefit of topical applications of a new product (P-3075).
A randomized, multicenter, double-blind, placebo-controlled, parallel-group, pilot study was carried out to evaluate the efficacy and tolerability of a cream (P-3075) based on 5% potassium azeloyl diglycinate (PAD, Azeloglicina®) and 1% hydroxypropyl chitosan (HPCH). Forty-two patients (rosacea stages I and II) were enrolled and randomized, 28 in the P-3075 group and 14 in the placebo group. They were asked to apply the cream twice daily for 4 weeks. The main assessments were the objective quantification of erythema and skin hydration using the Mexameter® and Corneometer® devices, respectively. Clinical signs and symptoms were evaluated on a four-point scale.
The P-3075 cream applied for 28 days was effective in skin protection by reducing erythema, evaluated both instrumentally and clinically. In addition, the clinical assessments of other symptoms such as flushing, stinging, and burning supported the beneficial effect of the P-3075 cream.
The anti-inflammatory and moisturizing effects of potassium azeloyl diglycinate combined with the protective properties of HPCH allow the new product to be a good candidate for controlling signs and symptoms of rosacea.
PMCID: PMC3488300  PMID: 22360333
Azeloglicina®; erythema; potassium azeloyl diglycinate (PAD); rosacea; skin hydration
16.  Wrinkles 
Clinical Evidence  2008;2008:1711.
Skin disorders associated with photodamage from ultraviolet light include wrinkles, hyperpigmentation, tactile roughness, and telangiectasia, and are more common in people with white compared with other skin types. Wrinkles are also associated with ageing, hormonal status, smoking, and intercurrent disease.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent and treat skin wrinkles? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 20 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: alpha and beta hydroxyl acids, carbon dioxide laser, chemical peel, dermabrasion, facelifts, isotretinoin, natural cartilage polysaccharides (oral or topical), retinyl esters, sunscreens, tazarotene, tretinoin, variable pulse erbium:YAG laser, and vitamin C or E (topical).
Key Points
Skin disorders associated with damage by ultraviolet light include wrinkles, hyperpigmentation, tactile roughness, and telangiectasia, and are more common in white people compared with other skin types. Wrinkles are also associated with ageing, hormonal status, smoking, and intercurrent disease.
We don't know whether sunscreens or topical vitamins C or E prevent wrinkles, as no studies were found.
Exposure to ultraviolet light may be associated with photodamage to the skin. Guidelines suggest that avoiding direct sunlight, either by staying indoors or in the shade, or by wearing protective clothing, is the most effective measure for reducing exposure to ultraviolet light.
We don't know whether topical vitamins C or E improve the appearance of wrinkles, as studies have been small. These vitamins may cause stinging and erythema.
Topical tretinoin improves fine wrinkles compared with placebo cream in people with mild to moderate photodamage, but its effect on coarse wrinkles is unclear. Topical tretinoin may cause itching, burning, erythema, and skin peeling. Isotretinoin cream improves fine and coarse wrinkles compared with vehicle cream in people with mild to severe photodamage, but causes severe irritation of the face in 5%–10% of people.We don't know whether tazarotene is more effective than tretinoin at improving fine and coarse wrinkles in people with moderate photodamage, as studies have given inconclusive results. It can cause burning of the skin.
We don't know whether retinyl esters, topical or oral natural cartilage polysaccharides, alpha or beta hydroxyl acids, or chemical peels are beneficial.
We don't know whether dermabrasion is more effective at improving wrinkles compared with carbon dioxide laser treatment, as studies have given inconclusive results, but adverse effects are common with both treatments, especially erythema. We don't know whether variable pulse erbium:YAG laser treatment or facelifts improve wrinkles, as few studies were found.
PMCID: PMC2907965  PMID: 19445782
17.  Cutaneous Manifestations in Patients with Chronic Kidney Disease on Maintenance Hemodialysis 
ISRN Dermatology  2012;2012:679619.
Cutaneous disorders can precede or follow the initiation of hemodialysis treatment. We evaluated the prevalence of various dermatological manifestations in patients undergoing hemodialysis at least twice a week for minimum of three months at our center. Patients were excluded if they were undergoing hemodialysis less than twice a week or on hemodialysis secondary to ESRD following graft dysfunction. One hundred and forty-three patients were evaluated. Among them, there were 113 male and 30 females. Among the skin changes, pruritus accounted for 56%, Xerosis was observed in 52%, Diffuse blackish hyper pigmentation was seen in 40%. Skin infections was seen in 53% of patients, of these fungal, bacterial and viral infections were 27.2%, 14.6%, and 11.2%, respectively. Kyrle's disease was observed only in 6.9%. Other skin manifestations include eczema 4.8%, psoriasis 2.7%, and drug rash 2.1%. Nail changes were observed in 46 patients of whom 27 patients had onychomycosis. Other changes include discoloration, onycholysis, and splinter hemorrhages. Hair changes were observed in 21.7%. Mucosal changes were seen in 27.3%. In our study, pruritus, xerosis, and pigmentation were higher among skin changes. Recognition and management of some of these dermatological manifestations vastly reduce the morbidity and improve the quality of life.
PMCID: PMC3398619  PMID: 22830039
18.  Life Quality Impairment Caused by Hookworm-Related Cutaneous Larva Migrans in Resource-Poor Communities in Manaus, Brazil 
Hookworm-related cutaneous larva migrans (CLM) is a common but neglected tropical skin disease caused by the migration of animal hookworm larvae in the epidermis. The disease causes intense pruritus and is associated with important morbidity. The extent to which CLM impairs skin disease-associated life quality has never been studied.
A modified version of the Dermatology Life Quality Index (mDLQI) was used to determine skin disease-associated life quality in 91 adult and child patients with CLM, living in resource-poor communities in Manaus, Brazil. Symptoms and signs were documented and skin disease-associated life quality was semi-quantitatively assessed using mDLQI scores. The assessment was repeated two and four weeks after treatment with ivermectin.
Ninety-one point five percent of the study participants showed a considerable reduction of skin disease-associated life quality at the time of diagnosis. The degree of impairment correlated with the intensity of infection (rho = 0.76, p<0.001), the number of body areas affected (rho = 0.30; p = 0.004), and the presence of lesions on visible areas of the skin (p = 0.002). Intense pruritus, sleep disturbance (due to itching) and the feeling of shame were the most frequent skin disease-associated life quality restrictions (reported by 93.4%, 73.6%, and 64.8% of the patients, respectively). No differences were observed in skin disease-associated life quality restriction between boys and girls or men and women. Two weeks after treatment with ivermectin, skin disease-associated life quality improved significantly. After four weeks, 73.3% of the patients considered their disease-associated life quality to have returned to normal.
CLM significantly impaired the skin disease-associated life quality in child and adult patients living in urban slums in North Brazil. After treatment with ivermectin, life quality normalised rapidly.
Author Summary
Hookworm-related cutaneous larva migrans (CLM) is a parasitic skin disease common in developing countries with hot climates. In resource-poor settings, CLM is associated with considerable morbidity. The disease is caused by animal hookworm larvae that penetrate the skin and migrate aimlessly in the epidermis as they cannot penetrate the basal membrane. Particularly in the rainy season, the intensity of infection is high with up to 40 larval tracks in an affected individual. Tracks are very itchy and are surrounded by a significant inflammation of the skin. Bacterial superinfection is common and intensifies the inflammation. The psychosocial consequences caused by CLM have never been investigated. We showed that CLM causes skin disease-associated life quality impairment in 91 patients with CLM. Skin disease-associated life quality was significantly impaired. The degree of impairment correlated to the intensity of infection and the number of body areas affected. After treatment with ivermectin, life quality was rapidly restored.
PMCID: PMC3210737  PMID: 22087341
19.  Therapy of acute wounds with water-filtered infrared-A (wIRA) 
Water-filtered infrared-A (wIRA) as a special form of heat radiation with a high tissue penetration and with a low thermal load to the skin surface acts both by thermal and thermic as well as by non-thermal and non-thermic effects. wIRA produces a therapeutically usable field of heat in the tissue and increases tissue temperature, tissue oxygen partial pressure, and tissue perfusion. These three factors are decisive for a sufficient tissue supply with energy and oxygen and consequently as well for wound healing and infection defense.
wIRA can considerably alleviate the pain (with remarkably less need for analgesics) and diminish an elevated wound exudation and inflammation and can show positive immunomodulatory effects. wIRA can advance wound healing or improve an impaired wound healing both in acute and in chronic wounds including infected wounds. Even the normal wound healing process can be improved.
A prospective, randomized, controlled, double-blind study with 111 patients after major abdominal surgery at the University Hospital Heidelberg, Germany, showed with 20 minutes irradiation twice a day (starting on the second postoperative day) in the group with wIRA and visible light VIS (wIRA(+VIS), approximately 75% wIRA, 25% VIS) compared to a control group with only VIS a significant and relevant pain reduction combined with a markedly decreased required dose of analgesics: during 230 single irradiations with wIRA(+VIS) the pain decreased without any exception (median of decrease of pain on postoperative days 2-6 was 13.4 on a 100 mm visual analog scale VAS 0-100), while pain remained unchanged in the control group (p<0.001). The required dose of analgesics was 57-70% lower in the subgroups with wIRA(+VIS) compared to the control subgroups with only VIS (median 598 versus 1398 ml ropivacaine, p<0.001, for peridural catheter analgesia; 31 versus 102 mg piritramide, p=0.001, for patient-controlled analgesia; 3.4 versus 10.2 g metamizole, p=0.005, for intravenous and oral analgesia). During irradiation with wIRA(+VIS) the subcutaneous oxygen partial pressure rose markedly by approximately 30% and the subcutaneous temperature by approximately 2.7°C (both in a tissue depth of 2 cm), whereas both remained unchanged in the control group: after irradiation the median of the subcutaneous oxygen partial pressure was 41.6 (with wIRA) versus 30.2 mm Hg in the control group (p<0.001), the median of the subcutaneous temperature was 38.9 versus 36.4°C (p<0.001). The overall evaluation of the effect of irradiation, including wound healing, pain and cosmesis, assessed on a VAS (0-100 with 50 as indifferent point of no effect) by the surgeon (median 79.0 versus 46.8, p<0.001) or the patient (79.0 versus 50.2, p<0.001) was markedly better in the group with wIRA compared to the control group. This was also true for single aspects: Wound healing assessed on a VAS by the surgeon (median 88.6 versus 78.5, p<0.001) or the patient (median 85.8 versus 81.0, p=0.040, trend) and cosmetic result assessed on a VAS by the surgeon (median 84.5 versus 76.5, p<0.001) or the patient (median 86.7 versus 73.6, p=0.001). In addition there was a trend in favor of the wIRA group to a lower rate of total wound infections (3 of 46, approximately 7%, versus 7 of 48, approximately 15%, p=0.208) including late infections after discharge, caused by the different rate of late infections after discharge: 0 of 46 in the wIRA group and 4 of 48 in the control group. And there was a trend towards a shorter postoperative hospital stay: 9 days in the wIRA group versus 11 days in the control group (p=0.037). The principal finding of this study was that postoperative irradiation with wIRA can improve even a normal wound healing process.
A prospective, randomized, controlled, double-blind study with 45 severely burned children at the Children’s Hospital Park Schönfeld, Kassel, Germany, showed with 30 minutes irradiation once a day (starting on the first day, day of burn as day 1) in the group with wIRA and visible light VIS (wIRA(+VIS), approximately 75% wIRA, 25% VIS) compared to a control group with only VIS a markedly faster reduction of wound size. On the fifth day (after 4 days with irradiation) decision was taken, whether surgical debridement of necrotic tissue was necessary because of deeper (second degree, type b) burns (11 of 21 in the group with wIRA, 14 of 24 in the control group) or non-surgical treatment was possible (second degree, type a, burns). The patients treated conservatively were kept within the study and irradiated till complete reepithelialization. The patients in the group with wIRA showed a markedly faster reduction of wound area: a median reduction of wound size of 50% was reached already after 7 days compared to 9 days in the control group, a median reduction of wound size of 90% was already achieved after 9 days compared to 13 days in the control group. In addition the group with wIRA showed superior results till 3 months after the burn in terms of the overall surgical assessment of the wound, cosmesis, and assessment of effects of irradiation compared to the control group.
In a prospective, randomized, controlled study with 12 volunteers at the University Medical Center Charité, Berlin, Germany, within each volunteer 4 experimental superficial wounds (5 mm diameter) as an acute wound model were generated by suction cup technique, removing the roof of the blister with a scalpel and a sterile forceps (day 1). 4 different treatments were used and investigated during 10 days: no therapy, only wIRA(+VIS) (approximately 75% wIRA, 25% VIS; 30 minutes irradiation once a day), only dexpanthenol (= D-panthenol) cream once a day, wIRA(+VIS) and dexpanthenol cream once a day. Healing of the small experimental wounds was from a clinical point of view excellent with all 4 treatments. Therefore there were only small differences between the treatments with slight advantages of the combination wIRA(+VIS) and dexpanthenol cream and of dexpanthenol cream alone concerning relative change of wound size and assessment of feeling of the wound area. However laser scanning microscopy with a scoring system revealed differences between the 4 treatments concerning the formation of the stratum corneum (from first layer of corneocytes to full formation) especially on the days 5-7: fastest formation of the stratum corneum was seen in wounds treated with wIRA(+VIS) and dexpanthenol cream, second was wIRA(+VIS) alone, third dexpanthenol cream alone and last were untreated wounds. Bacterial counts of the wounds (taken every 2 days) showed, that wIRA(+VIS) and the combination of wIRA(+VIS) with dexpanthenol cream were able to inhibit the colonisation with physiological skin flora up to day 5 when compared with the two other groups (untreated group and group with dexpanthenol cream alone). At any investigated time, the amount of colonisation under therapy with wIRA(+VIS) alone was lower (interpreted as more suppressed) compared with the group with wIRA(+VIS) and dexpanthenol cream.
During rehabilitation after hip and knee endoprosthetic operations the resorption of wound seromas and wound hematomas was both clinically and sonographically faster and pain was reduced by irradiation with wIRA(+VIS).
wIRA can be used successfully for persistent postoperative pain e.g. after thoracotomy.
As perspectives for wIRA it seems clinically prudent to use wIRA both pre- and postoperatively, e.g. in abdominal and thoracic operations. wIRA can be used preoperatively (e.g. during 1-2 weeks) to precondition donor and recipient sites of skin flaps, transplants or partial-thickness skin grafts, and postoperatively to improve wound healing and to decrease pain, inflammation and infections at all mentioned sites. wIRA can be used to support routine pre- or intraoperative antibiotic administration or it might even be discussed to replace this under certain conditions by wIRA.
PMCID: PMC2831241  PMID: 20204084
water-filtered infrared-A (wIRA); wound healing; acute wounds; prospective, randomized, controlled, double-blind studies; reduction of pain; problem wounds; wound infections; infection defense; wound exudation; inflammation; thermal and non-thermal effects; thermic and non-thermic effects; energy supply; oxygen supply; tissue oxygen partial pressure; tissue temperature; tissue blood flow; visual analog scales (VAS); quality of life
20.  Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial 
Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients.
Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy.
Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully.
Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer.
Trial Registration Numbers: IRCT201206099979N1, ACTRN12612000837820
PMCID: PMC3838980  PMID: 24293782
Radiation-induced dermatitis; Hydrocortisone; Breast cancer; Radiotherapy
21.  Efficacy and Safety of an Advanced Formula Silicone Gel for Prevention of Post-Operative Scars 
Dermatology and Therapy  2013;3(2):157-167.
Scar formation is a natural part of the healing process that occurs when the skin repairs wounds caused by burns, trauma, surgery or disease. The appearance of scars often leads to adverse psychological effects, loss of self-esteem and the associated stigmatism and diminished quality of life. Silicones are emerging as the standard treatment for prevention of a wide range of scars. The present study evaluated the safety and efficacy of an advanced formula topical silicone gel for prevention of post-operative hypertrophic and keloid scars.
An open-label prospective trial was conducted. Patients who had undergone prior surgery (10 days–3 weeks) and having recent post-surgical scars were enrolled. Patients were asked to apply the gel twice daily to the affected areas for 3 months. Pigmentation, vascularity, pliability, height of scar and pain and pruritus in the scar were assessed. Photographs of scars were taken before commencement of treatment and at follow-up visits.
A total of 36 patients were enrolled. At baseline, height of the scar was 2–5 mm in 57.6 % (19/33) of the subjects which was reduced in subsequent visits (P < 0.05). Hyperpigmentation (score 3) was present in 91% (30/33) of patients at baseline and was reduced to normal (score 0) after 2 months of treatment in 40% (6/14) of patients (P = 0.0313). Vascularity (54.6%, 18/33) at baseline was also reduced over the 3 months period (P = 0.0313) A significant decrease (30%, 3/10) (P = 0.0313) in pliability was seen after 3 months of treatment from the baseline (57.6%, 19/33). Only two patients reported pruritus and pain at the baseline visit; one patient reported improvement after treatment. Itching was reported as an adverse drug reaction in two patients.
These preliminary findings suggest that advanced formula silicone gel is safe and effective in the prevention of hypertrophic and keloid scars; however, larger, controlled studies are warranted.
Electronic supplementary material
The online version of this article (doi:10.1007/s13555-013-0036-8) contains supplementary material, which is available to authorized users.
PMCID: PMC3889307  PMID: 24254957
Dermatology; Hypertrophic; Keloid; Post-operative scar; Silicone gel
22.  A Randomised Controlled Trial of Ion-Exchange Water Softeners for the Treatment of Eczema in Children 
PLoS Medicine  2011;8(2):e1000395.
In a randomized trial evaluating the effect of installation of ion-exchange water softeners in the households of children with eczema, the researchers found no evidence of improvement in eczema severity as compared to usual care in the study population.
Epidemiological studies and anecdotal reports suggest a possible link between household use of hard water and atopic eczema. We sought to test whether installation of an ion-exchange water softener in the home can improve eczema in children.
Methods and Findings
This was an observer-blind randomised trial involving 336 children (aged 6 months to 16 years) with moderate/severe atopic eczema. All lived in hard water areas (≥200 mg/l calcium carbonate). Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. The primary outcome was change in eczema severity (Six Area Six Sign Atopic Dermatitis Score, SASSAD) at 12 weeks, measured by research nurses who were blinded to treatment allocation. Analysis was based on the intent-to-treat population. Eczema severity improved for both groups during the trial. The mean change in SASSAD at 12 weeks was −5.0 (20% improvement) for the water softener group and −5.7 (22% improvement) for the usual care group (mean difference 0.66, 95% confidence interval −1.37 to 2.69, p = 0.53). No between-group differences were noted in the use of topical corticosteroids or calcineurin inhibitors.
Water softeners provided no additional benefit to usual care in this study population. Small but statistically significant differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias, since participants were aware of their treatment allocation. A detailed report for this trial is also available at
Trial registration
Current Controlled Trials ISRCTN71423189
Please see later in the article for the Editors' Summary
Editors' Summary
Eczema (sometimes referred to as atopic dermatitis) is a chronic, inflammatory skin condition that affects about 20% of school children in developed countries. Eczema is often associated with other conditions, such as asthma, hay-fever and food allergy and can cause intractable itching leading to thickened skin, bleeding, secondary infection, sleep loss, poor concentration, and psychological distress. Current topical treatments for eczema have side effects, for example, topical corticosteroids may cause skin thinning and the long term safety of topical tacrolimus and pimecrolimus has yet to be determined. Therefore, there is a lot of interest in exploring the benefits of non-pharmacological treatments that have no apparent side effects.
Water hardness (≥200 mg/l calcium carbonate) has become a recent focus of attention.
Why Was This Study Done?
In addition to some epidemiological evidence linking increased water hardness with increased eczema prevalence, there have been widespread anecdotal reports of improvement in the skin of children with eczema when the family has moved from a hard to a soft water area. In addition, some patients report how their eczema symptoms have rapidly improved following the installation of a water softener. However, to date there have been no relevant published trials evaluating the potential benefit of water softeners for eczema. Given the lack of evidence, the high public interest in their potential benefit and the low risk of adverse effects, the researcher conducted a study to assess whether the installation of an ion-exchange water softener reduces the severity of eczema in children with moderate to severe eczema.
What Did the Researchers Do and Find?
The researchers did a pilot study that showed that it was not possible to blind participants to their treatment allocation using real and “dummy” water softener units because the softened water produced more soap suds. So the researchers conducted an observer-blind randomised controlled trial in which they used trained research nurses to conduct an objective assessment of every participant's skin. The researchers recruited 336 children who all lived in hard water areas in England. Eligible children were aged 6 months to 16 years who had a diagnosis of eczema (in line with the UK working party's diagnostic criteria) and an eczema severity score of 10 or over. Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. Trained research nurses examined each child's skin at baseline and at 6, 12, and 16 weeks to record changes in eczema severity. The researchers also analysed any changes in symptoms over the study period such as, sleep loss and itchiness, the amount of topical corticosteroid/calcineurin inhibitors used, the Dermatitis Family Impact questionnaire and the health related Quality of Life (children's version).
Although both treatment groups improved in disease severity during the course of the trial, the researchers found no difference between the treatment groups in the main outcome—eczema severity. Similar finding were found for night movement (scratching) and the use of topical medications (creams/ointments applied to the skin), both of which were blinded to intervention status. Nevertheless, parents in the trial did report small health benefits, and just over 50% chose to buy the water softener at the end of the trial because of perceived improvements in the eczema and the wider benefits of water softeners. It is unclear how much of this effect can be explained by prior belief in the effectiveness of the water softeners for the treatment of eczema.
What Do These Findings Mean?
The results of this study suggest that water softeners provide no additional clinical benefit to usual care in children with eczema so the use of ion-exchange water softeners for the treatment of moderate to severe eczema in children should not be recommended. However, it is up to each family to decide whether or not the wider benefits of installing a water softener in their home are sufficient to consider buying one.
Additional Information
Please access these Web sites via the online version of this summary at
The UK's NHS presents information on eczema for patients and families
MedlinePlus gives information for patients, families, and caregivers on eczema and other similar conditions
The National Eczema Society in the UK provides information and a helpline for eczema patients, families, and caregivers
Medinfo provides information for eczema patients
Wikipedia has more information about water softening (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
PMCID: PMC3039684  PMID: 21358807
23.  Warts (genital) 
Clinical Evidence  2007;2007:1602.
External genital warts (EGWs) are sexually transmitted benign epidermal growths caused by the human papillomavirus (HPV), on the anogenital areas of both females and males. About 50-60% of sexually active women aged 18-49 have been exposed to HPV infection, but only 10-15% will have genital warts.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for external genital warts? What are the effects of interventions to prevent transmission of external genital warts? We searched: Medline, Embase, The Cochrane Library and other important databases up to February 2007 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 47 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: bi- and trichloroacetic acid; condoms; cryotherapy; electrosurgery; imiquimod; intralesional, topical, or systemic interferons; laser surgery; podophyllin; podophyllotoxin; surgical excision; and vaccines.
Key Points
External genital warts (EGWs) are sexually transmitted benign epidermal growths caused by the human papillomavirus (HPV), on the anogenital areas of both females and males. About 50-60% of sexually active women aged 18-49 have been exposed to HPV infection, but only 10-15% will have genital warts. Warts are more common in people with impaired immune systems, but, in people with adequate immune function, about a third can resolve spontaneously.Some lesions, particularly those that are pigmented, should be biopsied to rule out severe dysplasia or melanoma, but external genital warts rarely, if ever, progress to cancer.
Imiquimod 1% and 5% creams increase clearance of warts compared with placebo in patients without HIV, but we don't know if they are effective in people with HIV. Imiquimod 5% cream may be more likely to clear warts, but increases local irritation compared with 1% imiquimod cream.
Topical interferon increases wart clearance at 4 weeks compared with placebo. Topical interferon is preferred to systemic interferon, which has not been shown consistently to be effective, is expensive to use, and is associated with severe side effects.We don't know if intralesional interferon is effective, although it is time consuming and expensive to use.
Podophyllotoxin is more effective than placebo and probably as effective as podophyllin in clearing genital warts, but may be easier to use. Podophyllin may contain mutagenic compounds, and its formulation is unstandardised, so podophyllotoxin is the preferred treatment, despite the risk of local burning and bleeding.
There is consensus that bi- and trichloroacetic acid and cryotherapy are effective treatments for external genital warts, although we found no studies comparing them to placebo.
Surgical (scissor) excision and electrosurgery may be effective at clearing genital warts at 6 months compared with no treatment, but we don't know whether laser surgery is also effective.
Vaccines are effective in preventing infection and disease by HPV in young women. We don't know whether vaccines are effective in people other than young women.
We don't know whether condom use reduces the spread of HPV infection and genital warts.
PMCID: PMC2943795  PMID: 19454104
24.  Effect of Sertraline on Uremic Pruritus Improvement in ESRD Patients 
Background. Although uremic pruritus is a common and upsetting problem of chronic kidney disease, there is no approved treatment for it. This study was undertaken to find the efficiency of sertraline as a possible treatment for uremic pruritus. Methods. 19 ESRD patients under hemodialysis with severe chronic pruritus were randomly selected to participate in this before-after clinical trial. Before and after starting treatment with sertraline, a detailed pruritus history was obtained and pruritus graded by the 30-item inventory of pruritus that patients based on priorities grade allocated to 3 classes. Subjects were treated with sertraline 50 mg oral daily for four months, with monthly assessments of pruritus symptoms. Results. Before treatment with sertraline, the grade of pruritus in 9 (47.4%) patients was moderate and severe in 10 (52.6%) patients. After treatment, grade of pruritus in 11 (57.8%) patients was weak, 6 (31.5%) have moderate and only 2 (10.7%) patients have severe pruritus. Of 10 patients with severe pruritus, 5 (50%) patients experiencing weak pruritus, and 4 (40%) patients have moderate pruritus after treatment. Based on Wilcoxon signed-rank test, the difference between the grade of pruritus before and after treatment with sertraline was significant (P = 0.001). Conclusions. Although no definitive recommendation can be made regarding treatment of uremic pruritus, we found an increased antipruritic effect of sertraline in ESRD patients.
PMCID: PMC3437632  PMID: 22973512
25.  The Effects of Mucopolysaccharide Polysulphate on Hydration and Elasticity of Human Skin 
Background. Mucopolysaccharide polysulphate (MPS) has been used in medicine as an anti-inflammatory and antithrombotic agent for over 50 years. Its chemical structure permits considerable hydrogen bonding with adjacent water molecules, which effectively leads to hydration of the surrounding tissue. In addition, it stimulates endogenous hyaluronate synthesis, resulting in an increase in water-binding capacity and viscoelasticity of the skin. Objective. To study the efficacy of 0.1% MPS on hydration and elasticity of human skin. Methods. The first part of this study was a randomized double blind placebo-controlled study which included 60 female volunteers aged 30–45 years with dry skin, defined by Corneometer CM 825. The volunteers were treated with either 0.1% MPS or vehicle control. All subjects were asked to apply 1 g of cream to their face twice daily for a total period of 4 weeks. Skin hydration and elasticity were measured at baseline and week 4 with Corneometer CM 825 and cutometer MPA 580, respectively, at forehead and both cheeks. The second part of this study focused on the efficacy of 0.1% MPS on skin hydration after single application. 20 female volunteers aged 30–45 years with dry skin, defined by Corneometer CM 825, were recruited to the study. All subjects were asked to apply 2 g of 0.1% MPS cream on entirely randomly selected forearm. Skin hydration at the middle of both forearms was measured at baseline, immediately after application, and every 1 hour after application for a period of 10 hours. Results. 57 subjects (28 in vehicle control group, 29 in MPS) completed treatment protocol. The baseline skin hydration of both groups was not significantly different (P = 0.47). Hower, there was a statistically significant difference in skin hydration at 4 weeks between MPS and placebo group (P = 0.01). Skin elasticity was significantly improved at week 4 in both groups (vehicle-control, P < 0.01, and MPS, P < 0.01). However, no significant difference in skin elasticity between MPS and vehicle-control group was noted (P = 0.15). Lastly, there was a statistically significant improvement in skin hydration after a single application (P < 0.01). This improvement was maintained for 10 hours. Conclusions. MPS provided improvement of skin hydration but not skin elasticity in woman with dry skin, compared with vehicle control. And MPS improved the skin hydration for at least 10 hours after single application.
PMCID: PMC3130995  PMID: 21747841

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