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

Abstract

Background: Androgenetic alopecia (AGA) is the most common hair loss disorder seen in men. It can have an early onset but has also been associated with ageing and senescence. It often induces pronounced psychological impact. ALRV5XR, a new hair loss treatment herein evaluated, was designed to target multiple molecular pathways involved in hair growth and hair follicle stem cell biology. The main objectives of the study were the assessment of safety and efficacy profiles of ALRV5XR in men. Methods: This 24-week, parallel randomised, placebo-controlled, double-blinded clinical trial was performed in a USA community clinic. Healthy men (age 22À65) with AGA and belonging to the Hamilton-Norwood (HN) classification IÀVII and Fitzpatrick skin type (FST) IÀVI, were randomly allocated in a 1:1 ratio into ALRV5XR or placebo treatment groups. Dermatologist assessment, phototrichograms, and blood samples were obtained in a blinded fashion at baseline, 12 and 24 weeks. Subjects were given a masked treatment consisting of oral capsules, shampoo, conditioner, and follicle serum, which was intended for daily use. Efficacy was assessed via absolute and per cent changes in terminal hair (TH) density, and response rates. The trial was registered with clinicaltrials.gov (NCT04450589) and is completed. Findings: Forty-six subjects were enroled in the study, 23 allocated to the ALRV5XR treatment and 23 to the placebo group. Enrolment occurred from April 11 to October 23, 2018. Thirty-six subjects completed the trial (17 ALRV5XR, 19 placebo) and 11 subjects in each group were evaluable for TH outcomes. At 24 weeks, the absolute change in TH density improved by 21¢0 THs/cm 2 (95% CI: 9¢2À32¢8; p = 0¢0014), and the relative density increased by 16¢4% (95% CI: 7¢4%À25¢5%; p = 0¢0012). The odds ratio for being a responder ( 0 change) was 87¢4. TH density increased linearly and was not affected by HN, FST, ethnicity, age, or body mass index. All subjects in the ALRV5XR group responded to treatment while 81¢8% of the placebo group decreased TH density. ALRV5XR induced statistically significant changes in both decrease in vellus hair (VH) density as well as in concomitant increase of the TH/VH ratio when compared to placebo. ALRV5XR was well tolerated, and no adverse events were observed. Interpretation: ALRV5XR treatment resulted in clinically significant TH regrowth in men with AGA. Furthermore, it appeared to reverse the characteristic hair miniaturisation seen in this condition. When compared to results of published trials of standard therapy, ALRV5XR showed a multi-fold increase both in efficacy and in response rates. In addition, the continuance of TH regrowth from 12 to 24 weeks suggests that the normal structure and function of non-productive telogen follicles is restored and that a normal hair phenotype may be attained by extended ALRV5XR treatment. Funding: Arbor Life Labs.

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 ).…”

Hair regrowth treatment efficacy and resistance in androgenetic alopecia: A systematic review and continuous Bayesian network meta-analysis

“…In any case, it has been noted that AGA-miniaturized vellus-like hairs, are not definitively influenced by these drugs; consequently, they cannot be converted back to THs ( 5 , 8 , 9 ). In contrast, ALRV5XR, a novel botanical natural product treatment for AGA, showed significant TH regrowth and appeared to reverse miniaturized hairs ( 12 , 13 ). Individuals affected by AGA seeking therapy would benefit from both a safe option aimed to prevent further hair loss and, potentially, a treatment that might regenerate their normal scalp hair phenotype.…”