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

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/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.

Sex differences in clinical trials of ALRV5XR treatment of androgenetic alopecia and telogen effluvium

“…Previously, for ALRV5XR, we reported remarkable and clinically significant increases in TH regrowth when compared to other treatments (1,2). In these studies, both sexes had common TH but highly differential VH densities at baseline (see Supplementary Table S1).…”

“…This unique property suggests a novel mechanism of action for ALRV5XR. Interestingly, during induction of hair and skin regeneration, platelet-rich plasma (PRP), autologous stem cell therapy (ACST), and ALRV5XR act as activators of similar growth factor and cytokine subcellular routes, including the Wnt/β-catenin signaling pathway ( 1 , 2 , 7 ). Moreover, in a related but different matter, it can be observed that senescent alopecia (SA) and AGA display similar miniaturization and histologic features ( 8 ).…”

“…We previously reported clinically significant terminal hair (TH) regrowth in treatment with ALRV5XR with no adverse signals or events in two double-blinded randomized placebo-controlled trials (RCTs) in women and men with androgenetic alopecia (AGA) and telogen effluvium (TE) ( 1 , 2 ). We report herein the pertinent similarities and differences in outcomes of the trials between women and men.…”

“…We also report new secondary trichometric data that provides insight into the different hair regrowth dynamics observed in women and men. In these RCTs, TH was reported as hair with a diameter > 40 μm, and vellus or vellus-like hair (VH) with a diameter < 40 μm ( 1 , 2 ).…”

The new regenerative and innovative strategies in hair loss

“…Regarding the innovative strategies, the efficacy of a specific compound obtained from botanical extracts, vitamins, and minerals, called "ALRV5XR", has been tested by Feldman et al [1] with interesting results in a randomized, double-blinded, placebo-controlled clinical trial in female affected by androgenetic alopecia (AGA) and/or Telogen Effluvium [1]. ALRV5XR aimed to prolong anagen of hair follicle (HFs) and induce neogen in involuted HFs acting also via activation of the Wnt/b-Catenin cascade in HF stem cells and dermal papilla cells [1]. This kind of biomolecular pathway has been analyzed also during alternative regenerative strategies.…”