Safety and efficacy of ALRV5XR in women with androgenetic alopecia or telogen effluvium: A randomised, double-blinded, placebo-controlled clinical trial

Peter R Feldman, Klaus M Fiebig, Charles Piwko, Boris M Mints, Dennis Brown, Deborah J Cahan, Jaime Guevara-Aguirre, Peter R Feldman, Klaus M Fiebig, Charles Piwko, Boris M Mints, Dennis Brown, Deborah J Cahan, Jaime Guevara-Aguirre

Abstract

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/cm2 (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/cm2 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.

Keywords: Aging; Androgenetic alopecia; Botanical; COVID-19; Female pattern hair loss; Finasteride; Hair regeneration; Hair restoration; Menopause; Minoxidil; Multi-targeting; PRP; Regenerative medicine; Senescence; Stem cell; Telogen effluvium; Wnt/beta-catenin; Women's health.

Conflict of interest statement

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).

Figures

Fig. 1
Fig. 1
Profile of Randomised Controlled Trial. 72 subjects were assessed for eligibility which resulted in 21 subjects evaluated in the placebo group and 18 subjects evaluated in the ALRV5XR (treatment) group.
Fig. 2
Fig. 2
Sample Global Photographs and Corresponding Phototrichoscopy Computer Image Analysis at baseline, week 12 and week 24. Phototrichoscopy images for Subject: F008 were analysed with the TrichoSciencePro software (version 1.6): a: Baseline (BL) Global Frontal; b: BL Global Top; c: BL Global Vertex; d: BL Phototrichoscopy (PT); e: BL PT Processed (PR); f: BL PT PR & Tagged (TG); g: Week 12 (W12) PT Raw; h: W12 PT PR; i: W12 PT PR & TG; j: Week 24 (W24) PT Raw; k: W24 PT PRD; l: W24 PT PR & TG. This analysis resulted in the following sample measurements: Subject: F008; Sex: Female; Age: 54; Ethnicity: Hispanic; Ethnic Hair Type: Latin/Indian/Semitic; Fitzpatrick Skin Type: III; Diagnosis: Androgenetic Alopecia; Ludwig Class-Type: I-3; Phototrichoscopy Area of View: 5.51mm2; Phototrichoscopy Magnification: 35x.
Fig. 3
Fig. 3
Changes in Terminal Hair from Baseline Over 24 Weeks. Treatment group ALRV5XR was significantly superior to placebo group for both (a) Absolute Change in Terminal Hairs (P=0·0002) and (b) Per Cent Change in Terminal Hairs (P=0·0016). Linear regressions are shown as lines with 95% confidence intervals shown in grey.

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