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
| Autor: | Theodor W. May, Subbu Anandan, Jithendriya Madhukara, Ammani M. Jayaraaman, Jill Chitallia, Rachita Dhurat, Adolf Klenk, Pradyumna Vaidya |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Physiology Administration Topical Dermatology law.invention 030207 dermatology & venereal diseases 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Randomized controlled trial law Caffeine Clinical endpoint Medicine Humans Young adult Pharmacology Original Paper integumentary system business.industry Consolidated Standards of Reporting Trials Alopecia General Medicine Middle Aged Topical liquid Treatment Outcome chemistry Minoxidil 030220 oncology & carcinogenesis Finasteride business medicine.drug |
| Zdroj: | Skin pharmacology and physiology. 30(6) |
| ISSN: | 1660-5535 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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