A randomized controlled pilot study of a proprietary combination versus sunscreen in melasma maintenance.

BACKGROUND: Melasma is the commonest cause of facial hypermelanosis in skin type IV-VI. First-line treatment includes a triple combination containing topical corticosteroid and hydroquinone which have side effects on prolonged use. Chemical peels are a second-line management option with the laser being used in refractory cases, but the worsening of hyperpigmentation in darker skin types can occur following laser therapy. Sunscreen is a must to prevent relapses. AIMS AND OBJECTIVES: (i) To compare the effects of treatment with a proprietary combination (phenyl ethyl resorcinol, nonapeptide-1, aminoethyl phosphinic acid, antioxidants and sunscreen) versus sunscreen alone in limiting or reducing, melasma and preventing recurrence as a maintenance regimen after the initial use of triple combination,(ii) to evaluate the safety of the formulation studied, and (iii) to study the improvement of the quality of life of the patients after using the study formulation versus placebo. METHODS: It was a prospective double-blinded parallel-group randomized controlled pilot study. A total of 46 subjects were recruited by consecutive sampling methods and randomized to 23 each in case and control groups. The study period was eight months with three phases. Phase 1 constituted the application of triple combination for eight weeks by both groups followed by phase 2 with the case group applying proprietary medicine and the control group applying sunscreen. Phase 3 was a follow-up period to see the sustenance of results in both groups as well as any evidence of relapses. Sunscreen was applied in all three phases. RESULTS: Case group in the study showed improvement in the melasma severity score and mean melanin index as measured by mexameter but it did not attain statistical significance as compared to the control group. The melasma area and severity index score showed a consistent reduction in the case group, whereas it increased in the control group from baseline. LIMITATIONS: Small sample size and a short follow-up period of our study were major limitations. CONCLUSION: The proprietary combination, which has sunscreen as one of its constituents, is more effective in maintaining remission after triple combination without any added inconvenience of application of two separate preparations as compared to sunscreen alone.

Safety and efficacy of methotrexate (0.3 mg/kg/week) versus a combination of methotrexate (0.15 mg/kg/week) with cyclosporine (2.5 mg/kg/day) in chronic plaque psoriasis: A randomised non-blinded controlled trial.

BACKGROUND: Psoriasis is a chronic, inflammatory, relapsing and remitting disease with no cure till date. There is a paucity of trials using a combination of methotrexate (MTX) and cyclosporine (CsA) in chronic plaque psoriasis, due to fear of added toxicity, although they are time tested treatment options for monotherapy. AIMS: The study aimed to compare the efficacy and adverse effect profile of the standard recommended dose of MTX (i.e. 0.3mg/kg/week) versus a combination of reduced doses of MTX and CsA (i.e. MTX 0.15 mg/kg/week with CsA 2.5mg/kg/day) in patients with chronic plaque psoriasis. METHODS: Study design was a non-blinded randomised controlled trial. Patients of chronic plaque psoriasis with PASI more than 10 were randomised in 1: 1 allocation to receive either 0.3 mg/kg/week of intramuscular MTX injection or a combination of 0.15 mg/kg/week of intramuscular MTX injection and 2.5 mg/kg/day of CsA rounded off to the nearest 25 mg. Patients were followed up at every 2 weeks for 12 weeks. The doses were kept fixed throughout the study period. RESULTS: A total of 66 patients received MTX monotherapy, whereas 67 patients received the combination. At baseline, both groups were comparable in their BSA (P = 0.105, Student t-test) and PASI (P = 0.277, Student t-test), which reduced significantly at 12 weeks in both groups (P < 0.001, paired t-test). The achievement of PASI-75 (P = 0.005), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) was more in the combination group (Chi square test). Intention to treat analysis using Chi square test also showed better outcomes for PASI-75 (P = 0.027), PASI-90 (P < 0.001) and PASI-100 (P = 0.001) in the combination group. Combination group also had earlier onset of action (P = 0.001, Chi square test). There was no significant difference between the groups in terms of laboratory and clinical adverse events. LIMITATIONS: Non-blinded, no comparison with CsA monotherapy arm, no follow up beyond 12 weeks. CONCLUSION: The combination of reduced doses of MTX and CsA is more efficacious with earlier onset of action and similar adverse effects as with MTX monotherapy.

Oral isotretinoin for treating mucocutaneous human papillomavirus infections: A systematic review and meta-analysis.

INTRODUCTION: Some viral warts are refractory to treatment, some others tend to recur. Oral isotretinoin is useful against warts to varying degrees. OBJECTIVE: To determine the efficacy of oral isotretinoin for treating mucocutaneous human papillomavirus infections. METHODS: A systematic review and meta-analysis of studies published from the date of inception of the databases to December 30, 2017 were conducted. Randomized controlled trials or case series with ≥10 patients with mucocutaneous human papillomavirus infection who had received oral isotretinoin treatment were analyzed. The meta-analysis estimated the pooled odds ratio and pooled response rate. RESULTS: The review included eight studies. Trials of oral isotretinoin versus placebo treatment revealed that isotretinoin effectively treated mucocutaneous human papillomavirus infections (odds ratio: 43.8, 95% confidence interval: 9.7-198.8). The pooled estimate of the complete response rate of oral isotretinoin to mucocutaneous human papillomavirus was 67.7% (95% confidence interval: 49.5-81.7%). Another pooled estimation revealed that 83.9% (95% confidence interval: 59.7-94.9%) of patients exhibited at least 50% lesion clearance, whereas 12.3% with complete response experienced recurrence. LIMITATIONS: This meta-analysis had a small sample size and high inter-study heterogeneity. CONCLUSION: Oral isotretinoin is superior to placebo for treating mucocutaneous human papillomavirus infections, particularly plane warts. The recurrence rate and risk of severe side effects are low.

Clinimetric analysis of recently applied quantitative tools in evaluation of vitiligo treatment.

BACKGROUND: Vitiligo affects about 1% of the world's population, however, there is currently no universally used standardized measure to assess its response to treatment. OBJECTIVE: To find the most effective technique for the quantitative assessment of therapeutic results in vitiligo patients. MATERIALS AND METHODS: The study was performed in three stages: (1) Conducting an adapted Delphi survey to check current dermatologists' attitudes regarding the topic of study. (2) Conducting a pilot study that involves testing the selected digital image analysis software in the laboratory to validate future tasks. (3) The chief clinimetric study that implicates selecting actual vitiligo lesion models and evaluating them. RESULTS: Regarding the surface area measuring techniques, the most accurate results were gained through the digital image analysis for surface area, followed by point-counting technique. The digital image analysis for color measurement was accurate and reliable in getting a percentage representation of color improvement within the vitiligo lesions, in response to therapy. LIMITATIONS: Many dermatologists lack understanding of basic concepts about imaging techniques. The study does not include a traditional assessment method such as vitiligo area scoring index. CONCLUSION: Our designated digital image analysis technique was able to efficiently assess the changes that occur both on surface area and the color of vitiligo lesions in response to therapy.

A randomized controlled trial of topical benzoyl peroxide 2.5% gel with a low glycemic load diet versus topical benzoyl peroxide 2.5% gel with a normal diet in acne (grades 1-3).

BACKGROUND: The improvement in insulin resistance and acne lesions on low glycemic load diets in various studies suggests that diet plays a significant role in acne pathogenesis. AIMS: To compare the efficacy of a low glycemic load diet plus topical benzoyl peroxide 2.5% gel with that of only topical benzoyl peroxide 2.5% gel in grades 1, 2 and 3 of acne vulgaris. METHODS: In a randomized controlled trial, 84 patients with grades 1, 2 and 3 acne vulgaris were divided into two groups, to receive a low glycemic load diet and no dietary intervention respectively. Acne lesions (face) were scored and graded at baseline and 4, 8 and 12 weeks. Homeostasis model assessment of insulin resistance and body mass index were measured during the first and last visits. Statistical analysis was done with Statistical Package for the Social Sciences, version 17.0. RESULTS: Both groups showed significant reduction in acne counts at 12 weeks (P = 0.931) with no statistically significant difference between the groups. The differences in body mass index and homeostasis model assessment of insulin resistance between the groups were statistically significant (P = 0.0001). Group 1 showed reductions in body mass index and homeostasis model assessment of insulin resistance values at the end of the study, whereas group 2 did not. LIMITATIONS: Application of mild topical cleanser in both the groups might have contributed to the improvement in epidermal barrier function, and topical application of 2.5% of benzoyl peroxide gel in both groups contributed to the improvement in acne counts. CONCLUSIONS: A low glycemic load diet did not result in any significant improvement in acne counts.

Isotretinoin and dermatosurgical procedures.

Several early reports suggested that performance of dermatosurgical procedures in patients on oral isotretinoin is associated with abnormal skin healing, keloid or hypertrophic scar formation. However, this association has been recently questioned in some studies. This review examines this issue, analyzes the studies published and concludes that the recommendation made earlier about the need to avoid dermatosurgical procedures in patients on isotretinoin is based on inadequate and insufficient evidence and hence needs revision. The review also suggests that recent studies on the subject establish that performing such procedures is safe.

N-acetylcysteine in dermatology.

N-acetylcysteine is a mucolytic drug which is commonly used as an antidote for acetaminophen toxicity. It is a thiol compound, which acts as a donor of cysteine, leading to replenishment of glutathione and thus acts as an antioxidant. It also has anti-inflammatory effects, alters the levels of neurotransmitters, inhibits proliferation of fibroblasts and keratinocytes and causes vasodilatation. Due to these actions, n-acetylcysteine has found use in several dermatologic conditions in systemic and topical form. The drug has been used as an adjuvant in the management of conditions such as toxic epidermal necrolysis, drug hypersensitivity syndrome, trichotillomania, skin picking disorders and onychotillomania, ichthyoses, contact dermatitis, atopic dermatitis, melasma, pseudoporphyria, connective tissue diseases, wound healing and alopecia. It also has a role in protection from radiation-induced skin damage including photo-ageing, photocarcinogenesis and radiation dermatitis. Most indications in dermatology are supported by case reports, small case series and small trials. Higher quality of evidence is needed for its wider use. The drug is cheap and is generally safe with few adverse effects. Thus a greater role is possible for use of n-acetylcysteine in various skin conditions. This review explores the various uses of n-acetylcysteine in the field of dermatology, the evidence supporting the same, the possible mechanisms of action and the adverse effects of the drug.

Safety of important dermatological drugs (retinoids, immune suppressants, anti androgens and thalidomide) in reproductively active males with respect to pregnancy outcome: A brief review of literature.

Paternally transmitted damage to offspring is recognized as a complex issue. Each parent contributes 23 chromosomes to a child; hence, it is necessary to know the effects of both maternal and paternal pre-and peri-conceptional exposure to drugs on pregnancy outcome. While there are many studies on the effects of maternal drug exposure on pregnancy outcome, literature on paternal exposure is scarce. Of late however, paternal exposure has been receiving increasing attention. We present a brief review on the safety of commonly used drugs in dermatology, focused on retinoids, immune suppressants, anti androgens and thalidomide.

Intramatricial injections for nail psoriasis: An open-label comparative study of triamcinolone, methotrexate, and cyclosporine.

BACKGROUND: One of the most effective options available for treating psoriatic fingernails is intramatricial injection of triamcinolone acetonide. Efficacies of intramatricial methotrexate and cyclosporine have not been comparatively evaluated to date. METHODS: Ninety fingernails in 17 patients were assigned to three groups of thirty nails each, and treated with intramatricial injections of triamcinolone acetonide (10 mg/ml), methotrexate (25 mg/ml) and cyclosporine (50 mg/ml) respectively. Each nail was given two injections with a 6-week interval, and graded at 24 weeks using the Nail Psoriasis Severity Index. RESULTS: In both triamcinolone acetonide and methotrexate groups, 15 (50%) nails out of 30 showed >75% improvement. In the cyclosporine group, only ten (33%) nails showed >75% improvement. Side effects were most in the nails treated with cyclosporine. LIMITATIONS: The limited follow-up period of 24 weeks may have been insufficient for detecting delayed remissions. The number of patients was small and there was no randomization or blinding. The lack of a placebo/ no- treatment arm can be considered a limitation. CONCLUSIONS: Amongst the three drugs studied, intramatricial methotrexate injection yielded the most improvement with minimum side effects, results being comparable to intramatricial triamcinolone acetonide injection. Cyclosporine was the least effective drug, with the most side effects. Intramatricial injection therapy is a safe, economical, simple and effective therapeutic modality in the management of nail psoriasis.

Methotrexate iontophoresis versus coal tar ointment in palmoplantar psoriasis: A pilot study.

BACKGROUND: Palmoplantar psoriasis is often disabling and refractory to conventional therapy. Systemic drugs are indicated in its severe form, but side effects are a concern with their use. Methotrexate is one such systemic drug which is effective and cheap. To reduce systemic toxicity, methotrexate has been tried topically but results have been inconsistent due to poor drug penetration into the skin by passive diffusion. Iontophoresis may enhance its absorption and efficacy. AIM: To evaluate the efficacy and safety of topical methotrexate iontophoresis in comparison with coal tar ointment in the treatment of palmoplantar psoriasis. METHODS: Thirty-one patients with palmar and/or plantar psoriasis were selected for the study and 28 patients completed it. The side having more severe involvement was treated while the other palm/sole served as a control. Iontophoresis using methotrexate solution was carried out on the study palm/sole with the injectable preparation of methotrexate (50 mg/2 ml) once a week for the first 4 weeks and subsequently every two weeks, for a total of six sittings. The control palm/sole was treated with coal tar ointment on other days. Erythema, scaling, induration and fissuring scores were noted in both groups before and after treatment. RESULTS: Both study and control groups showed decreases in scores but the reduction was more in the study group, the difference being statistically significant. LIMITATIONS: Drawbacks of our study include the small sample size and the lack of follow-up. The study and control arms were not exactly matched and the study was not blinded. CONCLUSION: Methotrexate iontophoresis was safe and more effective than coal tar ointmentin palmoplantarpsoriasis.