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Caffeine-Based Topical Liquid versus Minoxidil 5% Solution For Balding And Hair Loss

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

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 endpoint was the percentage change in the proportion of anagen hairs from baseline to 6 months using a frontal and occipital Trichogramma.

Results: At 6 months, the group of the 5% minoxidil solution showed a mean improvement in anagen ratio of the Trichogramma of 11.68%, and the group of the 0.2% caffeine solution had an anagen improvement of 10.59%. The difference in 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.

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