An Open-label Randomized Multicenter Study Assessing The Noninferiority Of A Caffeine-based Topical | HairLossTalk Forums

An Open-label Randomized Multicenter Study Assessing The Noninferiority Of A Caffeine-based Topical

Discussion in 'Hair Loss and Alopecia Published Studies' started by alscarmuzza, Jan 11, 2018.

  1. alscarmuzza

    alscarmuzza Established Member

    Oct 13, 2010
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    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.

    Dhurat, Rachita1
    Chitallia, Jill1
    May, Theodor W.2
    Jayaraaman, Ammani M.3
    Madhukara, Jithendriya4
    Anandan, Subbu5
    Vaidya, Pradyumna6
    Klenk, Adolf7
    Skin Pharmacology & Physiology. Jan2018, Vol. 30 Issue 6, p298-305. 8p.
    Document Type:
    Author-Supplied Keywords:
    Anagen hairs
    Androgenetic alopecia
    Caffeine-based topical liquid
    Frontal trichogram
    Occipital trichogram
    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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