Efficacy and safety of a new 5% minoxidil formulation in male androgenetic alopecia: A randomized, placebo-controlled, double-blind, noninferiority study.
J Cosmet Dermatol
; 18(1): 215-220, 2019 Feb.
Article
en En
| MEDLINE
| ID: mdl-29659116
ABSTRACT
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.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Fármacos Dermatológicos
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Alopecia
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Cabello
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Minoxidil
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Cosmet Dermatol
Asunto de la revista:
DERMATOLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Alemania