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© The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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.

Details

Title
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
Author
Sarkar, Rashmi 1 ; Vartak, Suneel 2 ; Acharya, Shivani 3 ; Kursam, Nikhil Kumar 3 ; Mane, Amey 3 ; Mehta, Suyog 3 ; Charugulla, Sujeet Narayan 3   VIAFID ORCID Logo 

 Maulana Azad Medical College, Department of Dermatology, New Delhi, India (GRID:grid.414698.6) (ISNI:0000 0004 1767 743X) 
 C.L.A.I.M.S. Pvt Ltd, Mumbai, India (GRID:grid.497442.8) 
 Dr. Reddy’s Laboratories Pvt Ltd, Ameerpet, India (GRID:grid.462113.3) (ISNI:0000 0004 1767 1409) 
Pages
469-479
Publication year
2020
Publication date
Jun 2020
Publisher
Springer Nature B.V.
ISSN
21938210
e-ISSN
21909172
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3224047909
Copyright
© The Author(s) 2020. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.