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Randomized Controlled Trial
. 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

Rachita Dhurat  1 , Jill Chitallia, Theodor W May, Ammani M Jayaraaman, Jithendriya Madhukara, Subbu Anandan, Pradyumna Vaidya, Adolf Klenk
Affiliations
Randomized Controlled Trial

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

Rachita Dhurat et al. Skin Pharmacol Physiol. 2017.

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.

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Figures

Fig. 1
Fig. 1
CONSORT flow diagram. PPS, per protocol set.
Fig. 2
Fig. 2
Mean (±standard error, SE) of the rate of anagen hair (AR; %) by treatment and visit (baseline, after 3 months, and after 6 months).
See this image and copyright information in PMC

References

    1. Blumeyer A, Tosti A, Messenger A, Reygagne P, Del Marmol V, Spuls PI, et al. Evidence-based (S3) guideline for the treatment of androgenetic alopecia in women and in men. J Dtsch Dermatol Ges. 2011;9((suppl 6)):S1–S57. - PubMed
    1. Stenn K, Parimoo S, Zheng Y, Barrows T, Boucher M, Washenik K. Bioengineering the hair follicle. Organogenesis. 2007;3:6–13. - PMC - PubMed
    1. Paus R, Cotsarelis G. The biology of hair follicles. N Engl J Med. 1999;341:491–497. - PubMed
    1. Torres F. Androgenetic, diffuse and senescent alopecia in men: practical evaluation and management. Curr Probl Dermatol. 2015;47:33–44. - PubMed
    1. US Food and Drug Administration Drug facts - minoxidil 2% solution. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat... (accessed March 1, 2017).

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