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Efficacy and safety of a new 5% minoxidil formulation in male androgenetic alopecia: A randomized, placebo‐controlled, double‐blind, noninferiority study.

Authors :
Blume‐Peytavi, Ulrike
Kottner, Jan
Issiakhem, Zahida
Gautier, Stephanie
Tonner, Françoise
Bouroubi, Athmane
Wigger‐Alberti, Walter
Fischer, Tobias
Hoffmann, Rolf
Voisard, Jean‐Jacques
Source :
Journal of Cosmetic Dermatology; Feb2019, Vol. 18 Issue 1, p215-220, 6p
Publication Year :
2019

Abstract

Summary: Background: Androgenetic alopecia (AGA) is the most common cause of hair loss in men. Topical minoxidil solutions can help to treat AGA but have to be applied continuously to be effective. Objectives: A new minoxidil formulation with improved cosmetic characteristics (DC0120, Pierre‐Fabre Dermatologie) was tested for noninferiority vs a comparator minoxidil product (ALOSTIL®, Johnson & Johnson) in stimulating hair growth in men with AGA. Methods: Two 10 cm2 areas on the scalp of each subject were randomized to receive DC0120, the comparator, or one of their corresponding vehicles, applied twice per day for 16 weeks. Nonvellus target area hair count (TAHC) was measured within treatment areas at baseline (day 1) and after 8 and 16 weeks by digital phototrichogram. Results: Two hundred and twenty subjects were included and randomized, of which 210 completed the study. The mean change in nonvellus TAHC between baseline and week 16 was +22.0 hairs/cm2 (95% CI: 18.1; 25.9) in the DC0120 group and +20.5 hairs/cm2 (95% CI: 16.6; 24.4) in the comparator group. The adjusted mean difference in TAHC changes between the two treatments was +1.5 hairs/cm2 (95% CI −2.3; 5.2), with the lower 95% confidence interval above the noninferiority threshold of −7 hairs/cm2. This indicated that DC0120 was noninferior to the comparator. Both minoxidil treatments also increased nonvellus TAHC compared to vehicle groups at 8 and 16 weeks. No new safety signals were observed. Conclusions: DC0120 was as safe and effective as a similar marketed minoxidil product for stimulating hair growth in men with AGA. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
14732130
Volume :
18
Issue :
1
Database :
Complementary Index
Journal :
Journal of Cosmetic Dermatology
Publication Type :
Academic Journal
Accession number :
134360477
Full Text :
https://doi.org/10.1111/jocd.12541