NCT07107841

Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)

Blinded, Randomized, Controlled, Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for the Treatment of Androgenic Alopecia (Single Site)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Acorn Biolabs Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

(SINGLE SITE Study) The purpose of this clinical trial is to evaluate the safety and efficacy of the use of an autologous hair follicle derived secretome for androgenous alopecia. The secretome will be injected into the scalp at baseline, and days 30, 90, 180, 270 and 365. Hair growth will be quantitatively measured for density and thickness. PROs will also be collected from participants. This study will be run at a SINGLE SITE.

Detailed description

(SINGLE SITE Study) Androgenic alopecia is a common condition causing hair loss and baldness in both men and women. Approximately 80 million men and women are affected by the condition in the US alone. Although there are a number of products on the market, both over the counter and prescribed, used for androgenic alopecia, they are only somewhat effective to slow the progression. This trial will evaluate a new approach involving the injection of an autologous product made from the cellular secretions of hair follicles (secretome). Proteonomic analysis has demonstrated that this secretome contains anywhere from 2-22 times the bioactive components of platelet rich plasma (PRP) when compared within the same individual. The hypothesis is that repeat injections of autologous hair follicle-derived secretome will safely and effectively stimulate hair regrowth in men and women suffering from androgenic alopecia. The trial is a double-blind, randomized, placebo controlled study in 60 patients who are on a stable (\>6 months) regimen of minoxidil and 5 alfa-reductase inhibitors. The injections will be delivered at baseline (day 0), 30, 90, 180, 270 and 365 days as follows: * Each vial of secretome will be diluted with 2ml of saline * Each quadrant of the affected scalp will receive one vial of secretome * Injections will be delivered in a grid-like pattern with injections spaced \~1cm apart * Approximately 20 injections (0.1ml/injection) will be delivered to each alopecia affected quadrant

Conditions

• Androgenic Alopecia
• Alopecia
• Baldness

Interventions

Type	Name	Description
OTHER	Autologous Hair Follicle-Derived Secretome	Hair follicles are plucked, cultured and the product is the resulting cell secretions (secretome) collected from the conditioned media.
OTHER	Placebo Control	The same saline used for diluting the active treatment in will be used as a control.

Timeline

• Start date: 2025-10-16
• Primary completion: 2027-09-15
• Completion: 2027-09-15
• First posted: 2025-08-06
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States