Autologous Hair Follicle Secretome for Androgenic Alopecia

Not Applicable

Not yet recruiting

• Conditions: Androgenic Alopecia

• Registration Number: NCT07107841
• Lead Sponsor: Acorn Biolabs Inc.

Brief Summary

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.

Detailed Description

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. We hypothesize 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-15
• Primary Completion: 2027-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target Area Hair Counts (TAHC)	180 Days after Baseline	Non-vellus TAHC is the number of non-vellus (terminal) hairs within 1 cm² scalp
Safety	180 days from Baseline	Incidence rates of treatment-related adverse events compared between the active and placebo arm

Secondary Outcome Measures

Name	Time	Method
Mean Total Hair Density (vellus and non-vellus/terminal)	30, 90, 270 and 365 days	Mean Total Hair Density (vellus and non-vellus/terminal): measured by Trichoscan device
Patient Satisfaction	30, 90, 270 and 365 days	Patient satisfaction collected using a 5 point Likert scale
Hair thickness improvement	30, 90, 180, 270 and 365 days	Hair thickness improvement measured by Trichoscan device
Patient Global Impression of Change (PGIC)	180 and 365 days	Patient rated improvement in alopecia based on comparison of Baseline to follow-up time point

Trial Locations

Locations (1)

Ziering Medical; 🇺🇸 West Hollywood, California, United States