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

被引:35
作者
Dhurat, Rachita [1 ]
Chitallia, Jill [1 ]
May, Theodor W. [6 ]
Jayaraaman, Ammani M. [2 ]
Madhukara, Jithendriya [4 ]
Anandan, Subbu [3 ]
Vaidya, Pradyumna [5 ]
Klenk, Adolf [7 ]
机构
[1] Lokmanya Tilak Municipal Gen Hosp, Mumbai, Maharashtra, India
[2] Chennai Meenakshi Multi Specialty Hosp, Chennai, Tamil Nadu, India
[3] Sri Ramachandra Med Coll & Hosp, Chennai, Tamil Nadu, India
[4] St Johns Med Coll & Hosp, Bengaluru, India
[5] Jehangir Clin Dev Ctr, Pune, Maharashtra, India
[6] GBP Soc Biometr & Psychometr, Bielefeld, Germany
[7] Dr Kurt Wolff GmbH & Co KG, Johanneswerkstr 34-36, DE-33611 Bielefeld, Germany
关键词
Androgenetic alopecia; Caffeine-based topical liquid; Anagen hairs; Frontal trichogram; Occipital trichogram; FOLLICLES IN-VITRO; HAIR-FOLLICLES; FOLLICULAR PENETRATION; MEN; PROLIFERATION;
D O I
10.1159/000481141
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
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. (C) 2017 S. Karger AG, Basel
引用
收藏
页码:298 / 305
页数:8
相关论文
共 19 条
[1]   Evidence-based (S3) guideline for the treatment of androgenetic alopecia in women and in men [J].
Blumeyer, Anja ;
Tosti, Antonella ;
Messenger, Andrew ;
Reygagne, Pascal ;
del Marmol, Veronique ;
Spuls, Phyllis I. ;
Trakatelli, Myrto ;
Finner, Andreas ;
Kiesewetter, Franklin ;
Trueeb, Ralph ;
Rzany, Berthold ;
Blume-Peytavi, Ulrike .
JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, 2011, 9 :S1-S57
[2]  
Bussoletti C, 2011, J APPL COSMETOL, V29, P167
[3]   Effect of caffeine and testosterone on the proliferation of human hair follicles in vitro [J].
Fischer, T. W. ;
Hipler, U. C. ;
Elsner, P. .
INTERNATIONAL JOURNAL OF DERMATOLOGY, 2007, 46 (01) :27-35
[4]   Differential effects of caffeine on hair shaft elongation, matrix and outer root sheath keratinocyte proliferation, and transforming growth factor-β2/insulin-like growth factor-1-mediated regulation of the hair cycle in male and female human hair follicles in vitro [J].
Fischer, T. W. ;
Herczeg-Lisztes, E. ;
Funk, W. ;
Zillikens, D. ;
Biro, T. ;
Paus, R. .
BRITISH JOURNAL OF DERMATOLOGY, 2014, 171 (05) :1031-1043
[5]   Caffeine's Mechanisms of Action and Its Cosmetic Use [J].
Herman, A. ;
Herman, A. P. .
SKIN PHARMACOLOGY AND PHYSIOLOGY, 2013, 26 (01) :8-14
[6]   MALE PATTERN BALDNESS - CLASSIFICATION AND INCIDENCE [J].
NORWOOD, OT .
SOUTHERN MEDICAL JOURNAL, 1975, 68 (11) :1359-1365
[7]   A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men [J].
Olsen, EA ;
Dunlap, FE ;
Funicella, T ;
Koperski, JA ;
Swinehart, JM ;
Tschen, EH ;
Trancik, RJ .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2002, 47 (03) :377-385
[8]   Follicular penetration of topically applied caffeine via a shampoo formulation [J].
Otberg, N. ;
Teichmann, A. ;
Rasuljev, U. ;
Sinkgraven, R. ;
Sterry, W. ;
Lademann, J. .
SKIN PHARMACOLOGY AND PHYSIOLOGY, 2007, 20 (04) :195-198
[9]   The biology of hair follicles [J].
Paus, R ;
Cotsarelis, G .
NEW ENGLAND JOURNAL OF MEDICINE, 1999, 341 (07) :491-497
[10]   Reporting of Noninferiority and Equivalence Randomized Trials Extension of the CONSORT 2010 Statement [J].
Piaggio, Gilda ;
Elbourne, Diana R. ;
Pocock, Stuart J. ;
Evans, Stephen J. W. ;
Altman, Douglas G. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 308 (24) :2594-2604