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Skin Pharmacol Physiol. 2017;30(6):298-305. doi: 10.1159/000481141. Epub 2017 Oct 21.

An Open-Label Randomized Multicenter Study Assessing the Noninferiority of a Caffeine-Based Topical Liquid 0.2% versus Minoxidil 5% Solution in Male Androgenetic Alopecia.

Author information

1
Lokmanya Tilak Municipal General Hospital, Mumbai, India.

Abstract

BACKGROUND:

Androgenetic alopecia is a condition with a high prevalence worldwide and affects both males and females. Currently, only 2 approved treatments exist: finasteride (males only) and minoxidil 2 or 5% solution (males and females).

METHODS:

We conducted a randomized, open-label, multicenter noninferiority study to determine whether a caffeine-based 0.2% topical liquid would be no less effective than minoxidil 5% solution in males (n = 210) with androgenetic alopecia. The primary end point was the percentage change in the proportion of anagen hairs from baseline to 6 months using a frontal and occipital trichogram.

RESULTS:

At 6 months, the group of the 5% minoxidil solution showed a mean improvement in anagen ratio of the trichogram of 11.68%, and the group of the 0.2% caffeine solution had an anagen improvement of 10.59%. The difference of mean values between both groups was 1.09%. The statistical analysis was performed and reported in accordance with the CONSORT Guidelines 2010 for reporting of noninferiority and equivalence randomized trials.

CONCLUSION:

A caffeine-based topical liquid should be considered as not inferior to minoxidil 5% solution in men with androgenetic alopecia.

KEYWORDS:

Anagen hairs; Androgenetic alopecia; Caffeine-based topical liquid; Frontal trichogram; Occipital trichogram

PMID:
29055953
PMCID:
PMC5804833
DOI:
10.1159/000481141
[Indexed for MEDLINE]
Free PMC Article

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