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Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.

ABSTRACT: INTRODUCTION:Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia. METHODS:In this randomized double-blind study, patients aged???18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp. RESULTS:All screened patients (N?=?100) were enrolled and randomized to TP (n?=?33), RP1 (n?=?33), or RP2 (n?=?34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups. CONCLUSIONS:Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations. TRIAL REGISTRATION:Clinical Trial Registry of India; CTRI/2018/11/016431.

SUBMITTER: Sarkar R

PROVIDER: S-EPMC7211774 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.

Sarkar Rashmi R Vartak Suneel S Acharya Shivani S Kursam Nikhil Kumar NK Mane Amey A Mehta Suyog S Charugulla Sujeet Narayan SN

Dermatology and therapy 20200410 3

<h4>Introduction</h4>Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia.<h4>Methods</h4>In this randomized double-blind study, patients ...[more]

PMID: 32277388

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Project description:BackgroundAndrogenetic alopecia (AGA) is the most common cause of hair loss in men with limited treatment options. Platelet-rich plasma (PRP) therapy is one of the newer treatment options in the management of AGA which has shown promising results.Aims and objectivesThis study was aimed at comparing the clinical efficacy of PRP therapy with minoxidil therapy.Materials and methodsIn the study, patients were randomized into two groups - Group A (given PRP therapy) and Group B (given minoxidil therapy). Both groups were followed up over a period of 6 months, and final analysis was done with the help of global photography, hair pull test, standardized hair growth questionnaire, patient satisfaction score; in addition, a comparison of platelet counts in PRP was done, to know that if a clinical correlation exists between platelet concentration and clinical improvement. A total of 40 patients clinically diagnosed with AGA were enrolled in the study with 20 patients in each group. Four patients from Group A (PRP) and six patients from Group B (minoxidil) could not complete the treatment for 6 months and were eventually excluded.ResultsAt the end of 6 months, 30 patients were evaluated to compare the efficacy of intradermal PRP and topical minoxidil therapy. On global photography, Group A (PRP) was found to have a comparatively better outcome than Group B (minoxidil). In hair pull test, hair growth questionnaire, and patient satisfaction score, Group A was found to be better than Group B. Mean platelet count at baseline was 3.07 ± 0.5 lac/mm, 3 while platelet count in final PRP prepared was 12.4 ± 1.7 lac/mm, and patients with a higher platelet count in PRP had a much better clinical improvement compared to patients with a low platelet count in PRP. Side effects with PRP therapy were minimal with better results which may improve the compliance of the patient.ConclusionPRP therapy can be a valuable alternative to topical minoxidil therapy in the treatment of AGA.

Project description:BackgroundA myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy.ObjectiveEvaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.MethodologyA total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.ResultsBoth therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).ConclusionBoth topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.ClinicaltrialsGov identifierNCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .

Project description:BackgroundOral finasteride is a well-established treatment for men with androgenetic alopecia (AGA), but long-term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles.ObjectivesTo evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride.MethodsThis randomized, double-blind, double dummy, parallel-group, 24-week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone and dihydrotestosterone (DHT) concentrations were measured.ResultsOf 458 randomized patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs. 6.7 hairs; P < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at week 12 and investigator-assessed change from baseline in patient hair growth/loss at week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs. 55.6%), with topical vs. oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride.ConclusionTopical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations.

Dataset Information

Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.

Publications

Comparative Study to Evaluate Tolerability of Topical 5% Minoxidil Novel Formulation and Alcohol-Based Conventional Solutions in Treatment of Androgenetic Alopecia in Indian Men: Randomized Double-Blind Study.

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