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1.  Central Neuropathic Pain in a Patient with Multiple Sclerosis Treated Successfully with Topical Amitriptyline 
Case Reports in Medicine  2012;2012:471835.
Central neuropathic pain in patients with multiple sclerosis (MS) is a common debilitating symptom, which is mostly treated with tricyclic antidepressants or antiepileptics. Unfortunately, the use of these drugs is often limited due to adverse events. We investigated the analgesic effect of topical amitriptyline 5% and 10% cream in a patient with central neuropathic pain due to MS. The analgesic effect of topical amitriptyline cream on neuropathic pain was dose related. To evaluate whether this analgesic effect is due to the active compound or placebo, we conducted a double-blind placebo-controlled n-of-1 study with amitriptyline 5% cream and placebo. The instruction was to alternate the creams every week following the pattern ABAB, with an escape possibility of amitriptyline 10% cream. The result was a complete pain reduction after application of cream B, while most of the time cream A did not reduce the pain. The patient could correctly unblind both creams, determining B as active. She noted that in the week of using the active cream no allodynia was present, with a carryover effect of one day.
doi:10.1155/2012/471835
PMCID: PMC3407646  PMID: 22851976
2.  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 
Background
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.
Methods/Designs
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.
Discussion
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
doi:10.1186/1748-717X-7-121
PMCID: PMC3419129  PMID: 22849762
3.  The Clinical Efficacy of Mometasone Furoate in Multi-Lamellar Emulsion for Eczema: A Double-blinded Crossover Study 
Annals of Dermatology  2013;25(1):17-22.
Background
Topical application of corticosteroids also has an influence on skin barrier impairment. Physiological lipid mixtures, such as multi-lamellar emulsion (MLE) containing a natural lipid component leads to effective recovery of the barrier function.
Objective
The purpose of this study was to conduct an evaluation of the therapeutic efficacy and skin barrier protection of topical mometasone furoate in MLE.
Methods
A multi-center randomized, double-blind, controlled study was performed to assess the efficacy and safety of mometasone furoate cream in MLE for Korean patients with eczema. The study group included 175 patients with eczema, who applied either mometasone furoate in MLE cream or methylprednisolone aceponate cream for 2 weeks. Treatment efficacy was evaluated using the physician's global assessment of clinical response (PGA), trans-epidermal water loss (TEWL), and visual analogue scale (VAS) for pruritus. Patients were evaluated using these indices at days 4, 8, and 15.
Results
Comparison of PGA score, TEWL, and VAS score at baseline with those at days 4, 8, and 15 of treatment showed a significant improvement in both groups. Patients who applied mometasone furoate in MLE (74.8%) showed better results (p<0.05) than those who applied methylprednisolone aceponate (47.8%). The TEWL improvement ratio was higher in the mometasone furoate in MLE group than that in the methylprednisolone aceponate group, and VAS improvement was also better in the mometasone furoate in MLE group.
Conclusion
Mometasone furoate in MLE has a better therapeutic efficacy as well as less skin barrier impairment than methylprednisolone aceponate.
doi:10.5021/ad.2013.25.1.17
PMCID: PMC3582923  PMID: 23467551
Ceramide; Corticosteroid; Eczema; Multi-lammelar emulsion; Skin-barrier
4.  Clinical and instrumental assessment of the effects of a new product based on hydroxypropyl chitosan and potassium azeloyl diglycinate in the management of rosacea 
Summary
Background
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.
Aim
To assess the benefit of topical applications of a new product (P-3075).
Patients/Methods
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.
Results
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.
Conclusions
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.
doi:10.1111/j.1473-2165.2011.00598.x
PMCID: PMC3488300  PMID: 22360333
Azeloglicina®; erythema; potassium azeloyl diglycinate (PAD); rosacea; skin hydration
5.  Efficacy of omega-3 fatty acids supplementation in treatment of uremic pruritus in hemodialysis patients: a double-blind randomized controlled trial 
Background
Uremic pruritus is a common and bothersome complaint among end-stage renal disease which affect between 25% and 60% of this population .But there is no decisive cure for treatment of it. In this study, the effects of omega-3 for treatment of pruritus were investigated in hemodialysis patients.
Methods
A double-blind randomized study was carried out in the form of placebo-controlled crossover study in four dialysis centers in Tehran, Iran during 2008. At first, 22 hemodialysis patients suffering from pruritus with previous drug resistance were selected. Next, these patients were randomly allocated into two groups of omega-3-placebo (group A) and placebo-omega-3 (group B) .Patients in group A were treated with a 1-gram Fish oil capsule for 20 days, and subsequently, they were treated with placebo for 20 days after a 14-day wash-out period .But the reverse act was done in group B.The pruritus assessment was made quantitatively through Detailed Pruritus Score.
Results
Pruritus was decreased up to 65% from score mean of 20.3 (95% CI: 16.7-23.8) to 6.4 (95% CI: 2.9-9.8) in omega-3 group and the decrease in the placebo group was 15% from score mean of 17.0 (95% CI: 12.4-21.6) to 14.4 (95% CI: 10.5-18.2).So the level of statistical difference was significant (P=0.0001).
Discussion
Omega-3 fatty acids found to be more effective than placebo in decreasing of uremic pruritus. So it seems that Omega-3 fatty acids could be used as an efficient drug for treatment of pruritus in uremic patients.
PMCID: PMC3482323  PMID: 23115713
Fatty Acids; Omega-3; Fish Oils; pruritus; Renal Dialysis; Uremia
6.  Effects of Oral L-Carnitine Supplementation on Lipid Profile, Anemia, and Quality of Life in Chronic Renal Disease Patients under Hemodialysis: A Randomized, Double-Blinded, Placebo-Controlled Trial 
In patients on maintenance hemodialysis several factors reduce the body stored carnitine which could lead to dyslipidemia, anemia, and general health in these patients. We evaluated the effect of oral L-carnitine supplementation on lipid profiles, anemia, and quality of life (QOL) in hemodialysis patients. In a randomized, double-blinded, placebo-controlled trial, end-stage renal disease (ESRD) patients on hemodialysis received either L-carnitine 1 g/d (n = 24) or placebo (27 patients) for 16 weeks. At the end of the study, there was a significant decrease in triglyceride (−31.1 ± 38.7 mg/dL, P = 0.001) and a significant increase in HDL (3.7 ± 2.8 mg/dL, P < 0.001) levels in the carnitine group. Decrease in total cholesterol (−6.6 ± 16.0 mg/dL, P = 0.075) and increase in hemoglobin (0.7 ± 1.7 g/dL, P = 0.081) concentrations in the carnitine group were not significant. There was no statistically significant changes in LDL in any group (P > 0.05). Erythropoietin dose was significantly decreased in both the carnitine (−4750 ± 5772 mg, P = 0.001) and the placebo group (−2000 ± 4296 mg, P < 0.05). No improvement was observed in QOL scores of two groups. In ESRD patients under maintenance hemodialysis, oral L-carnitine supplementation may reduce triglyceride and cholesterol and increase HDL and hemoglobin and subsequently reduce needed erythropoietin dose without effect on QOL.
doi:10.1155/2012/510483
PMCID: PMC3374945  PMID: 22720143
7.  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
8.  Vapocoolant Spray vs Lidocaine/Prilocaine Cream for Reducing the Pain of Venipuncture in Hemodialysis Patients: A Randomized, Placebo-Controlled, Crossover Study 
Objective: Patients undergoing hemodialysis are repeatedly exposed to stress and pain from approximately 300 punctures per year to their arteriovenous fistula. This study was designed to measure pain associated with venepuncture during AVF cannulation and to compare the effectiveness of ethyl chloride vapocoolant spray, topical eutectic mixture of local anesthetics (EMLA) cream and placebo in controlling pain caused by venepuncture of arteriovenous fistula patients undergoing chronic hemodialysis.
Methods: This randomized, placebo-controlled, crossover study, included 41 patients undergoing conventional hemodialysis three times a week. First intervention was conducted as baseline pain assessment (control). In the three consecutive dialysis sessions, every patient randomly received 1) ethyl chloride vapocoolant spray, 2) EMLA, or 3) placebo cream before venepuncture. Pain perception was recorded by patients immediately after cannulation on a 0-100 mm visual analogue scale (VAS). p<0.05 was considered as significant.
Results: VAS scores presented a marked inter-individual variation during venepuncture. EMLA application resulted in significantly lower total pain scores compared to control and all other interventions (p<0.05). No patient experienced severe pain with EMLA or vapocoolant. The patients reported less moderate and severe pain with EMLA, and vapocoolant spray compared to control and placebo interventions. Moderate and severe pain scores were similar between EMLA and vapocoolant spray (p>0.05).
Conclusion: Venipuncture for AVF cannulation causes mild to moderate pain in hemodialysis patients. Although local application of EMLA is more effective than in preventing venepuncture pain, ethyl chloride vapocoolant is as effective as EMLA for preventing mild to moderate puncture pain in patients undergoing hemodialysis.
PMCID: PMC3198258  PMID: 22022215
Hemodialysis; arteriovenous fistula; venepuncture pain; vapocoolant spray; visual analogue scale
9.  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.
doi:10.1208/s12249-011-9641-y
PMCID: PMC3134674  PMID: 21671201
ethanol; ethylene oxide; gamma irradiation; scaffold; sericin
10.  The Effects of Fumaria Parviflora L Extract on Chronic Hand Eczema: A Randomized Double-Blind Placebo Controlled Clinical Trial 
Background
Hand eczema is a common and distressing condition with multiple causes such as atopy, irritant and allergic contact dermatitis. Fumaria parviflora, is known as Shahtareh in Persian, is a folk medicine for eczema. This study aimed to evaluate the effect of alcoholic extract of Fumaria parviflora on hand eczema.
Methods
In a randomized double-blind, placebo-controlled study, 44 patients with hand eczema were randomly assigned to apply 4% cream of Fumaria parviflora or vehicle cream to hand twice daily for 4 weeks.
Results
The reduction of eczema area and severity index score before and two weeks after therapy was statistically significant between vehicle treated and in treated group. Only one patient showed side effects such as erythema and population.
Conclusion
Fumaria parviflora appears to be tolerated by most patients and the findings showed that its extract may be considered as an effective agent for treatment of chronic hand eczema.
PMCID: PMC3371888  PMID: 22737422
Eczema; Fumaria parviflora; Fumaric acid
11.  The Effect of EMLA Cream on Patient-Controlled Analgesia with Remifentanil in ESWL Procedure: A Placebo-Controlled Randomized Study 
Anesthesiology and Pain Medicine  2013;2(3):119-122.
Background
To alleviate stinging pain in the skin entry area and visceral discomfort in patients who are undergoing ESWL.
Objectives
This study was designed to investigate the effectiveness of the EMLA cream in combination with remifentanil patient-controlled analgesia (PCA) in patients undergoing ESWL treatment.
Patients and Methods
Sixty patients were divided into two double-blind randomized groups. Those in the first group were administered 3-5mm of EMLA 5% cream on a marked area; the second group received, as a placebo, a cream with no analgesic effect in the same amount. All patients were administered a remifentanil bolus with a PCA device. Arterial blood pressure, oxygen saturation, and respiratory rate were recorded throughout the procedure; postoperative side effects, agitation, and respiratory depression were measured after. Visual Analogue Scale (VAS) scores were taken preoperatively, perioperatively, directly postoperatively, and 60 minutes subsequent to finishing the procedure.
Results
There were no statistically significant differences in the frequency of PCA demands and delivered boluses or among perioperative VAS. No significant side effects were noted. Patient satisfaction was recorded high in both groups.
Conclusions
EMLA cream offered no advantage over the placebo cream in patients undergoing ESWL with remifentanil PCA.
doi:10.5812/aapm.7790
PMCID: PMC3821126  PMID: 24244921
Lithotripsy; Remifentanil; Analgesia, Patient-Controlled; EMLA
12.  Pimecrolimus Cream 1% in the Management of Atopic Dermatitis in Pediatric Patients: A Meta-Analysis 
PLoS ONE  2014;9(4):e93095.
Objective
To evaluate the efficacy and safety of pimecrolimus cream 1% in the treatment of AD in the pediatric population.
Methods
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.
Results
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)
Conclusion
The results of the present meta-analysis showed that pimecrolimus cream 1% was not significantly better to vehicle for AD in pediatrics population.
doi:10.1371/journal.pone.0093095
PMCID: PMC3972203  PMID: 24691404
13.  Substance P and intensity of pruritus in hemodialysis and peritoneal dialysis patients 
Background
Uremic pruritus is a common complication in patients undergoing dialysis. The pathophysiological mechanisms of pruritus in patients with end-stage renal disease remain unknown. Neuropeptides, including substance P, are postulated to play an important role in the pathogenesis of pruritus. The aim of this study was to evaluate the role of substance P in uremic pruritus in patients on hemodialysis and peritoneal dialysis.
Material/Methods
We included 197 patients with end-stage renal disease: 54 on continuous ambulatory peritoneal dialysis and 143 on hemodialysis. Substance P, calcium, phosphorus, iron, ferritin, CRP, albumin, hemoglobin, Ca × P product, and iPTH level were determined in all participants. The correlation between these parameters and self-reported itching was evaluated in patients on hemodialysis in comparison with peritoneal dialysis patients.
Results
The incidence of itching was similar in hemodialysis and peritoneal dialysis patients. No differences in substance P level between the 2 groups were found. There was no correlation between substance P level and the incidence or intensity of pruritus in dialyzed patients.
Conclusions
This study demonstrates that substance P does not play any important role in pruritus in hemodialysed and peritoneal dialyzed patients. However, further studies are necessary to assess the exact role of neuropeptides in uremic pruritus.
doi:10.12659/MSM.889349
PMCID: PMC3767586  PMID: 23995243
substance P; uremic pruritus; end-stage renal disease; hemodialysis; peritoneal dialysis
14.  Effect of aromatherapy on pruritus relief in hemodialysis patients 
BACKGROUND:
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.
METHODS:
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.
RESULTS:
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).
CONCLUSIONS:
Aromatherapy can significantly relieve pruritus in hemodialysis patients.
PMCID: PMC3203284  PMID: 22049288
Aromatherapy; pruritus; hemodialysis
15.  The treatment of melasma by silymarin cream 
BMC Dermatology  2012;12:18.
Background
Melasma is an acquired increased pigmentation of the skin characterized by symmetrical and confluent grey-brown patches usually on the areas of the face exposed to the sun. Silymarin strongly prevents photocarcinogenesis, and significantly prevented melanin production. The objectives of this study were the assessment of safety and efficacy of topical Silymain (SM) cream in a double-blind placebo controlled study for treatment of melasma patients.
Methods
Experimentally on 24 Albino rabbits were randomly divided into 4 equal groups. [A] No treatment, [B] received placebo, [C] treated with SM cream (0.1), & [D] treated by SM (0.2), were applied topically before UV sun light exposure for 30 days, assessed clinically & tissue pathology. Clinically on 96 adults diagnosed with melasma randomized to three equal groups to receive one of the tested drugs applied twice daily for 4 weeks, evaluated by the response; lesion size, melasma area and severity index score, Physician global assessment, and subjective assessment.
Results
The Clinical and histopathology observations were reduced significantly in SM groups. Clinically; all patients showed significant excellent pigment improvement & lesion size reduction with SM treatments from the 1st week. All patients were fully satisfied 100%. No side effects were observed.
Conclusions
Silymarin showed tremendous improvement of melasma in a dose-dependent manner, and was effective in prevention of skin damage caused by U.V. sunlight. It is a safe new candidate effective treatment for melasma.
Trial registration
Australian New Zealand Clinical Trials Registry - ACTRN12612000602820
doi:10.1186/1471-5945-12-18
PMCID: PMC3519762  PMID: 23031632
Silymarin; Melasma; Sunlight
16.  MULTICENTRIC, PLACEBO-CONTROLLED, RANDOMISED DOUBLE-BLIND EVALUATION OF A NEW HERBAL CREAM IN VAGIAL INFECTIONS 
Ancient Science of Life  1995;14(4):212-224.
Efficacyand safety of a new herbal cream containing aqueous extracts of Azadirachta indica, Curcuma longa, Pongamia glabra, Glycyrrihiza glabra and Santallum album were evaluated in amulticentric, randomized, double-blind, placebo-controlled study. With active drug treatment, there was significant improvement in various signs like redness, oedema and symptoms like itching, burning, discharge and discomfort, compared to placebo treatment. Microscopic examination of smear and culture showed significant reduction of offending organisms after treatment with active drug. In patient's global evaluation, active drug was rated 70% as very good and in investigators evaluation 82% as very effective and effective. The overall efficacy was as high as 76% with active drug as against only 24% with placebo. Both active drug and placebo were well tolerated.
PMCID: PMC3331252  PMID: 22556701
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.
doi:10.5402/2012/679619
PMCID: PMC3398619  PMID: 22830039
18.  Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms 
One of the most common conditions affecting end-stage renal disease (ESRD) patients undergoing hemodialysis (HD) is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%–90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124) undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315). The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being “moderately” to “extremely bothered” by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization – higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units) and intravenous (IV) iron (237.2 to 247.6 units) and higher use of IV antibiotics (14.1% to 20.7%), as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey). These results highlight the need to better identify and manage ESRD patients impacted by pruritus, as this symptom is associated with negative clinical outcomes and increased resource utilization. Further studies are needed to evaluate the current economic burden of pruritus in ESRD patients and create possible options for an improved pharmacoeconomic profile in this patient population.
doi:10.2147/IJNRD.S52985
PMCID: PMC3872274  PMID: 24379689
pruritus; end-stage renal disease; hemodialysis; itchiness; patient reported outcomes
19.  Comparison of terbinafine and clotrimazole in treating tinea pedis. 
BMJ : British Medical Journal  1993;307(6905):645-647.
OBJECTIVE--To compare the efficacy and safety of terbinafine 1% cream and clotrimazole 1% cream in the treatment of tinea pedis. DESIGN--Multicentre, double blind parallel group study. SETTING--32 general practices and one hospital. PATIENTS--256 patients with mycologically confirmed tinea pedis. Of the 211 patients evaluable, 107 were randomised to terbinafine (75 male, 32 female; mean (range) age 40 (12-81) years) and 104 to clotrimazole (79 male, 25 female; mean (range) age 36 (12-71) years). INTERVENTIONS--Terbinafine 1% cream applied twice daily for one week and inert cream applied twice daily for the next three weeks. Clotrimazole 1% cream applied twice daily for four weeks. MAIN OUTCOME MEASURES--Mycological cure (negative results on microscopy and culture) and effective treatment (mycological cure plus no or minimal signs and symptoms) measured at weeks 1, 2, 3, 4, and 6. RESULTS--At week four rates of mycological cure were 93.5% for terbinafine and 73.1% for clotrimazole (p = 0.0001); and at week six 97.2% for terbinafine and 83.7% for clotrimazole (p = 0.001). Rates of effective treatment at week 4 were 89.7% for terbinafine and 58.7% for clotrimazole (p = 0.0001); and 89.7% for terbinafine and 73.1% for clotrimazole (p = 0.002) at week 6. CONCLUSION--These results indicate that a one week course of terbinafine 1% cream is more effective in the treatment of tinea pedis than a four week course of clotrimazole 1% cream, both in terms of mycological cure and effective treatment.
PMCID: PMC1679014  PMID: 8401048
20.  First-Line Therapy for Human Cutaneous Leishmaniasis in Peru Using the TLR7 Agonist Imiquimod in Combination with Pentavalent Antimony 
Background
Current therapies for cutaneous leishmaniasis are limited by poor efficacy, long-term course of treatment, and the development of resistance. We evaluated if pentavalent antimony (an anti-parasitic drug) combined with imiquimod (an immunomodulator) was more effective than pentavalent antimony alone in patients who had not previously been treated.
Methods
A randomized double-blind clinical trial involving 80 cutaneous leishmaniasis patients was conducted in Peru. The study subjects were recruited in Lima and Cusco (20 experimental and 20 control subjects at each site). Experimental arm: Standard dose of pentavalent antimony plus 5% imiquimod cream applied to each lesion three times per week for 20 days. Control arm: Standard dose of pentavalent antimony plus placebo (vehicle cream) applied as above. The primary outcome was cure defined as complete re-epithelization with no inflammation assessed during the 12 months post-treatment period.
Results
Of the 80 subjects enrolled, 75 completed the study. The overall cure rate at the 12-month follow-up for the intention-to-treat analysis was 75% (30/40) in the experimental arm and 58% (23/40) in the control arm (p = 0.098). Subgroup analyses suggested that combination treatment benefits were most often observed at the Cusco site, where L. braziliensis is the prevalent species. Over the study period, only one adverse event (rash) was recorded, in the experimental arm.
Conclusion
The combination treatment of imiquimod plus pentavalent antimony performed better than placebo plus pentavalent antimony, but the difference was not statistically significant.
Trial Registration
Clinical Trials.gov NCT00257530
Author Summary
Neglected tropical diseases (NTDs) are a group of tropical infections including trypanosomiasis, filariasis, schistosomiasis, onchocerciasis, leishmaniasis and other such diseases of poverty. Of the classic neglected diseases, leishmaniasis has among the highest level of morbidity and mortality. Infection with Leishmania parasites causes severe disease in humans, including fatal visceral leishmaniasis and cutaneous leishmaniasis resulting in severe scarring, often in the face. This is a difficult infection to treat because the current therapies are generally poorly effective. The present study carried out a placebo-controlled, double-blinded study to investigated whether a combined therapy with imiquimod plus pentavalent antimony was superior to the standard therapy of pentavalent antimony alone as a first-line treatment for cutaneous leishmaniasis in Peru. A higher cure rate with the combination therapy was observed, but could not be conclusively proven.
doi:10.1371/journal.pntd.0000491
PMCID: PMC2710502  PMID: 19636365
21.  Successful treatment of herpes labialis with topical acyclovir. 
A double blind, placebo controlled trial of 5% acyclovir cream, applied topically five times a day for five days, was carried out in 49 patients with recurrent herpes labialis. These patients had a total of 74 episodes, 34 of which were treated with the 5% acyclovir cream and 40 with matching placebo. First episodes and all episodes treated with acyclovir cream had significantly shorter times to formation of ulcer or crust and to complete healing (p less than 0.05 for all variables). The duration of all symptoms and proportion of patients developing itching was also reduced by acyclovir cream in first episodes, though the difference was not significant. When the patient started treatment early in the course of a first episode acyclovir cream significantly reduced the percentage of lesions progressing beyond the papular stage (p less than 0.05). Acyclovir cream is well tolerated and effective for the treatment of recurrent herpes labialis.
PMCID: PMC1548234  PMID: 6405939
22.  Imiquimod 5-Percent Cream Does Not Alter the Natural History of Recurrent Herpes Genitalis: a Phase II, Randomized, Double-Blind, Placebo-Controlled Study 
Antimicrobial Agents and Chemotherapy  2002;46(10):3243-3248.
Present strategies for control of herpes genitalis recurrences require multiple daily doses of antiviral medication. Imiquimod, an immune response modifier, induces alpha interferon and interleukin-12; application in the presence of local herpes antigens during a recurrence may augment herpes simplex virus (HSV)-specific cell-mediated immunity. To test this theory, we performed a randomized, double-blind, placebo-controlled study of imiquimod 5% cream to assess safety and efficacy for decreasing recurrences. Patients with six or more recurrences of herpes genitalis per year applied study cream (imiquimod or placebo) to lesions one, two, or three times per week for 3 weeks for each recurrence during a 16-week treatment period. This was followed by a 16-week observation period. Of 124 patients randomized to the study, 103 completed the treatment period and 93 completed the observation period. The median times to first genital herpes recurrence were 53 days for those receiving placebo (n = 30) and 54, 60, and 64 days for those receiving imiquimod one time per week (n = 34), two times per week (n = 32), and three times per week (n = 28), respectively. The median annualized recurrence rates during the treatment period were 3.8, 4.9, 3.2, and 3.1, respectively. There were no statistically significant differences in the time to first recurrence or in the annualized recurrence rate between the imiquimod and placebo groups in either the treatment or the observation period. A trend in increased rates of local adverse events at the application site and a delay in lesion healing with more frequent dosing suggested a pharmacologic effect. Although clinical efficacy has been observed for imiquimod in other conditions in which a TH1-type immune response may be beneficial, including other viral infections such as those caused by human papillomavirus, no apparent effect on the short-term natural history of herpes genitalis recurrences was observed.
doi:10.1128/AAC.46.10.3243-3248.2002
PMCID: PMC128805  PMID: 12234851
23.  A Phase 2a Study of Topical Perillyl Alcohol Cream for Chemoprevention of Skin Cancer 
Chemopreventive and antitumor properties of perillyl alcohol (POH) studied preclinically indicate that topical POH inhibits both ultraviolet B (UVB)-induced murine skin carcinogenesis (squamous cell tumor models) and DMBA-induced murine melanoma (transgenic models involving tyrosinase-driven Ras). A previous Phase 1 clinical trial in participants with normal-appearing skin demonstrated that topical POH cream was well tolerated at a dose of 0.76% (w/w). Here we performed a three month, double-blind, randomized, placebo-controlled Phase 2a trial of two different doses of topical POH in individuals with sun-damaged skin. Participants applied POH cream twice daily to each dorsal forearm. Baseline and end-of-study biopsies were taken from each participant to evaluate whether the topical application of POH was effective in reversing actinic damage as evidenced by normalization of quantitative skin histopathologic scores and change in nuclear chromatin pattern measured by karyometric analysis. There was a borderline reduction in the histopathologic score of the lower dose of POH compared to placebo (p = 0.1), but this was not observed in the high dose group. However, in the high dose group, a statistically significant reduction in the proportion of nuclei deviating from normal was observed using karyometric analysis (p< 0.01). There was no statistical significance demonstrated in the lower dose group. No changes were observed in p53 expression, cellular proliferation (by PCNA expression), or apoptosis in either treatment group compared to placebo. These results suggest that while our karyometric analyses can detect a modest effect of POH in sun-damaged skin, improved delivery into the epidermis may be necessary.
doi:10.1158/1940-6207.CAPR-09-0183
PMCID: PMC3270887  PMID: 20103724
Chemoprevention; topical perillyl alcohol; karyometry; skin cancer; histopathologic score
24.  Effect of Vitamin C Supplementation on C-reactive Protein Levels in Patients Undergoing Hemodialysis: A Randomized, Double Blind, Placebo-Controlled Study 
Nephro-urology Monthly  2013;6(1):e13351.
Background:
Chronic inflammation is the most important cause of cardiovascular disease in patients undergoing hemodialysis, and vitamin C as a major antioxidant which could be effective to suppress inflammation.
Objectives:
This study was performed to evaluate the effect of vitamin C supplementation on C-reactive protein levels in patients undergoing hemodialysis.
Patients and Methods:
This randomized, placebo-controlled and double-blind trial was conducted on 151 patients on hemodialysis who were divided randomly by lottery method to three identical groups. In the intervention group, 250 mg of vitamin C was injected intravenously immediately at the end of each hemodialysis session three times a week for 8 weeks in a row. In the control group 1, same term of placebo saline was injected, and in the control group 2, no intervention was performed.
Results:
A total of 86 (61%) male and 55 female patients with mean hemodialysis duration of 39.74 ± 45.5 months, and a mean age of 61.36 ± 11.46 years-old, participated in this study. Hypertension and diabetes were the most common underlying diseases (79.4%). Median baseline CRP in the intervention, control 1 and control 2 groups were 16.8, 17.8, and 19.4 mg/L respectively. After 2 months, median CRP reduced significantly in the vitamin C group to 10.7 (P = 0.04) vs. 22.6, and 30.6 mg/L in control groups.
Conclusions:
Our findings demonstrated that vitamin C supplementation modifies the levels of CRP in patients on hemodialysis.
doi:10.5812/numonthly.13351
PMCID: PMC3968960  PMID: 24719806
Renal Insufficiency, Chronic; Renal Dialysis; C- Reactive Protein; Ascorbic Acid
25.  Topical Insulin Accelerates Wound Healing in Diabetes by Enhancing the AKT and ERK Pathways: A Double-Blind Placebo-Controlled Clinical Trial 
PLoS ONE  2012;7(5):e36974.
Background
Wound healing is impaired in diabetes mellitus, but the mechanisms involved in this process are virtually unknown. Proteins belonging to the insulin signaling pathway respond to insulin in the skin of rats.
Objective
The purpose of this study was to investigate the regulation of the insulin signaling pathway in wound healing and skin repair of normal and diabetic rats, and, in parallel, the effect of a topical insulin cream on wound healing and on the activation of this pathway.
Research Design and Methods
We investigated insulin signaling by immunoblotting during wound healing of control and diabetic animals with or without topical insulin. Diabetic patients with ulcers were randomized to receive topical insulin or placebo in a prospective, double-blind and placebo-controlled, randomized clinical trial (NCT 01295177) of wound healing.
Results and Conclusions
Expression of IR, IRS-1, IRS-2, SHC, ERK, and AKT are increased in the tissue of healing wounds compared to intact skin, suggesting that the insulin signaling pathway may have an important role in this process. These pathways were attenuated in the wounded skin of diabetic rats, in parallel with an increase in the time of complete wound healing. Upon topical application of insulin cream, the wound healing time of diabetic animals was normalized, followed by a reversal of defective insulin signal transduction. In addition, the treatment also increased expression of other proteins, such as eNOS (also in bone marrow), VEGF, and SDF-1α in wounded skin. In diabetic patients, topical insulin cream markedly improved wound healing, representing an attractive and cost-free method for treating this devastating complication of diabetes.
Trial Registration
ClinicalTrials.gov NCT01295177
doi:10.1371/journal.pone.0036974
PMCID: PMC3360697  PMID: 22662132

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