An Exosome Regenerative Complex Plus Microneedling Promotes Hair Growth in Subjects With Self-Perceived Thinning Hair

October 2025 | Volume 24 | Issue 10 | 9244 | Copyright © October 2025


Published online September 30, 2025

Glynis Ablon MD FAAD

Ablon Skin Institute and Research Center, Manhattan Beach, CA

Abstract
Thinning hair affects the quality of life of affected men and women but has limited treatment options. A novel technology refines exosomes from stem cells to create a concentrated complex that is quickly absorbed into the scalp to deliver growth factors, peptides, coenzymes, minerals, amino acids, and vitamins (Exosome Regenerative Complex+®. BENEV, Inc.; Mission Viejo, CA). This study assessed the efficacy and safety of the Exosome Regenerative Complex applied following microneedling on the scalp of subjects with self-perceived thinning hair. Enrolled subjects were male (n=15) and female (n=15) with a mean (SD) age of 50.2 (10.9) years (range, 26-65 years). Subjects were treated on days 0, 30, 60, and 90, with a final assessment on day 120. Trichoscopy assessments showed this treatment significantly increased terminal and vellus hair counts (P<0.0001) and decreased hair shedding on day 120 (P<0.01), increased mean follicular units per cm² (P<0.0001), and decreased inter-follicular distance (P<0.0001). On day 120, the investigator rating for improved hair quality was 97% and improved hair growth was 83%. Subject satisfaction with treatment results was high with no reported adverse events. The combined use of an Exosome Regenerative Complex combined with RF microneedling appears to be an effective and well-tolerated treatment for hair loss in men and women.

ClinicalTrials.gov NCT06571799.

INTRODUCTION

Androgenetic alopecia (AGA) is a non-scarring hair loss characterized by gradual miniaturization of hair follicles and shortening of successive anagen cycles.1 It is the most common form of hair loss affecting men and women.2 Prevalence differs by gender and race, with >50% of older men and approximately 15% of postmenopausal women affected.2 Regardless of the cause, hair loss has significant impacts, especially on women.3

Treatment options for hair loss are limited as only topical minoxidil, oral finasteride, and photobiomodulation are US Food and Drug Administration (FDA)-approved therapies.4,5 One hair loss treatment under investigation is microneedling,6 which is presumed to stimulate collagen formation, neovascularization, and production of growth factors,7 and which enhances their beneficial effects when combined with other topical hair loss treatments.6,7

Exosomes are extracellular vesicles derived from endoplasmic reticulum that transport various biomolecules necessary for normal intercellular physiology and intercellular communication.8,9 In dermatology, exosomes represent promising new medical treatments for wound healing,10 psoriasis,11 atopic dermatitis,12 and facial rejuvenation.13 There has been recent interest in the use of exosomes for hair restoration,14-16 particularly those derived from mesenchymal- and adipose-derived stem cells.17,18

A recent study combined microneedling with topical exosomes for treating male subjects with mild-to-moderate AGA (n=16).19 Baseline hair densities ranged from 75 to 95 hairs/cm2, increasing by 35 (6.5) hairs/cm2 after 12 months. These results suggest exosome therapy combined with microneedling is a beneficial treatment for AGA.

An innovative technology separates and refines pure exosomes from stem cells (ExoSCRT™. BENEV, Inc.; Mission Viejo, CA), resulting in a dual-action complex formulated to be quickly absorbed into the skin and scalp to deliver concentrated stem cell material containing lyophilized exosomes, potent growth factors, peptides, coenzymes, minerals, amino acids, and vitamins (Exosome Regenerative Complex+®. BENEV, Inc.; Mission Viejo, CA). Previous work demonstrated that exosomes

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