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

Peter R Feldman; Oriel J Feldman; Jaime Guevara-Aguirre; Klaus M Fiebig

doi:10.3389/fmed.2022.918058

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

Front Med (Lausanne). 2022 Aug 4:9:918058. doi: 10.3389/fmed.2022.918058. eCollection 2022.

Authors

Peter R Feldman¹, Oriel J Feldman^{1

2}, Jaime Guevara-Aguirre^{3

4

5

6}, Klaus M Fiebig¹

Affiliations

¹ Arbor Life Labs, Toronto, ON, Canada.
² Faculty of Science, Wilfrid Laurier University, Waterloo, ON, Canada.
³ College of Medicine, Universidad San Francisco de Quito, Quito, Ecuador.
⁴ Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.
⁵ Institute of Endocrinology, Metabolism, and Reproduction, Quito, Ecuador.
⁶ College of Medicine, University of Florida, Gainesville, FL, United States.

Abstract

Introduction: ALRV5XR treatment of androgenetic alopecia (AGA) and telogen effluvium (TE) has early evidence of regenerating a normal scalp hair phenotype in both sexes.

Design: We performed two 24-week double-blinded placebo-controlled comparison trials, one in each sex, on the ALRV5XR treatment effect on hair regeneration, in AGA and TE, in 92 AGA subjects (24 also had TE). Forty-six women (age 24-64 years) and 46 men (age 22-63 years) were randomized 1:1 to either ALRV5XR or placebo regimens (one b.i.d. oral capsule and daily administration of shampoo, conditioner, and follicle serum).

Evaluation: Primary outcomes: Absolute and relative changes in terminal hair (TH) density. Secondary outcomes: Response rate, changes in vellus hair (VH) density, TH/VH ratio, hair diameter, growth, and shedding rate.

Results: Forty-one women (20 ALRV5XR, 21 placebo) and 36 men (17 ALRV5XR, 19 placebo) completed the trials. TH outcome was evaluable for 18 and 21 women and 11 and 11 men (ALRV5XR, placebo, respectively). Efficacy in women: 30.1 THs/cm² (p = 0.0002) and 19.7% (p = 0.0016). Efficacy in men: 21.0 THs/cm² (p = 0.0014) and 16.4% (p = 0.0012). 66.7% of women and 100% of men responded to ALRV5XR. TH/VH ratio for men increased 33.0% (p = 0.0033). Growth rate in women increased by 30.7 μm/24 h (p < 0.0001) and 10.0% (p < 0.0001). There were no adverse events reported.

Conclusion and relevance: ALRV5XR induced significant regrowth of TH. Accelerating regrowth by reactivation of dormant telogen follicles were the dominant effects in women. Thickening of miniaturized hair and regrowth of dormant telogen follicles contributed equally to the increased TH seen in men (see Graphical Abstract).

Keywords: ALRV5XR; androgenetic alopecia; hair regrowth dynamics; hair restoration; miniaturization reversal; pattern hair loss; regenerative medicine; telogen effluvium.