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Open-Label Randomized Multicenter

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 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.

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Dr. Robert Jones

Dr. Robert Jones is recognized worldwide as an innovator in hair transplant techniques. He is a medical professional whose commitment to providing a high-quality surgical outcome is paramount.

He has been practicing medicine ever since earning his degree in 1979 from McMaster University’s Department of Medicine. He also took continuing education courses in cosmetic laser surgery at both Harvard and Loyola Universities.

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