Safety and efficacy of ALRV5XR in women with androgenetic alopecia or telogen effluvium: A randomised, double-blinded, placebo-controlled clinical trial.
| Autor: | Feldman PR; Arbor Life Labs, Toronto, Ontario, Canada., Fiebig KM; Arbor Life Labs, Toronto, Ontario, Canada., Piwko C; CHP Pharma Inc, Thornhill, Ontario, Canada., Mints BM; B&B International, Vilnius, Lithuania., Brown D; Valent Technologies, Menlo Park, California, USA., Cahan DJ; Arbor Life Labs, Toronto, Ontario, Canada., Guevara-Aguirre J; Universidad San Francisco de Quito (USFQ), Quito, Ecuador.; Institute of Endocrinology, Metabolism, and Reproduction (IEMYR), Quito, Ecuador.; Maastricht University, Maastricht, The Netherlands.; College of Medicine, University of Florida, Gainesville, Florida, USA. |
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| Jazyk: | angličtina |
| Zdroj: | EClinicalMedicine [EClinicalMedicine] 2021 Jun 24; Vol. 37, pp. 100978. Date of Electronic Publication: 2021 Jun 24 (Print Publication: 2021). |
| DOI: | 10.1016/j.eclinm.2021.100978 |
| Abstrakt: | Background: Scalp hair loss (alopecia) in women is a common ageing and senescing condition. It usually presents as androgenetic alopecia (AGA) or telogen effluvium (TE) and often has pronounced psychological consequences. ALRV5XR is a novel treatment aiming to regenerate a normal hair phenotype by targeting multiple molecular pathways linked to hair growth promotion and hair follicle stem cell activation. The primary objectives of this 24-week trial were to evaluate the safety and efficacy of ALRV5XR in terminal hair (TH) regrowth in women with AGA or TE. Methods: This randomised, double-blind, placebo-controlled trial was performed in a USA community clinic. Healthy women 18-65 years of age with AGA or TE of Ludwig classification I-II and Fitzpatrick skin type I-VI were enrolled. They were allocated in a 1:1 ratio into ALRV5XR or placebo treatment groups using a random number table. Masked dermatologist assessments, phototrichograms and blood samples were obtained at baseline, 12 and 24 weeks. Subjects were given a masked treatment regimen of oral capsules, shampoo, conditioner and follicle serum for daily administration. Main outcomes were absolute and per cent changes in TH density and response rates. The trial was registered with clinicaltrials.gov (NCT04450602) and is completed. Findings: 46 subjects (23 ALRV5XR, 23 placebo) were enrolled between April 3 and October 20, 2018. Five subjects dropped out and two were non-compliant. Thirty-nine subjects completed the trial (18 ALRV5XR, 21 placebo). At 24 weeks, the absolute change in TH density improved by 30·1THs/cm 2 (95% CI: 15·1-45·1; p=0·0002), and the relative density increased by 19·7% (95% CI: 8·0%-31·4%; p=0·0016). The odds ratio for being a responder (≥0 change) was 2·7. Efficacy increased 133% from week 12 to 24. Efficacy outcomes were similar in AGA and TE subjects. 66·7% of the ALRV5XR group responded by regrowing 40THs/cm 2 or more hair. No adverse events were reported. Interpretation: In women with AGA or TE, ALRV5XR treatment significantly increased hair regrowth without adverse events. ALRV5XR displayed a multi-fold improved efficacy and response rate when compared to published trials of standard therapy. Progressive acceleration of TH regrowth suggests regeneration of the structure and function of non-productive telogen follicles and prolonged treatment may restore a normal hair phenotype. Competing Interests: PRF is the director of Arbor Life Labs (ALL), PRF, DJC and DB are coinventors of patents filed for ALRV5XR and have a share in ALL. PRF, KMF, CP, BMM, DJC and JG, received honoraria from ALL and proposed submission for publication. PRF, DB and DJC have a share in ALL. All authors had full access to the data in the study. (© 2021 The Author(s).) |
| Databáze: | MEDLINE |
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