Actively Recruiting
Blinded, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for the Treatment of Androgenic Alopecia (Single Site)
Led by Acorn Biolabs Inc. · Updated on 2026-02-12
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an autologous hair follicle-derived secretome as a treatment for androgenic alopecia, a common cause of hair loss affecting men and women. This trial aims to study the safety and effectiveness of injecting this secretome into the scalp compared to a saline placebo. The study will include 60 patients who have been on a stable regimen of minoxidil and 5-alpha reductase inhibitors for at least six months. Participants will receive injections of the secretome diluted with saline or placebo at baseline and on days 30, 90, 180, 270, and 365. The injections will be administered in a grid-like pattern across affected areas of the scalp, with about 20 injections per quadrant. Each vial of secretome is diluted in 2ml saline, and each quadrant receives one vial. The study is double-blind and placebo-controlled. During the trial, hair growth will be measured by density and thickness at various time points, and patient-reported outcomes will be collected. Safety will be monitored, with assessments including Target Area Hair Counts and patient satisfaction. Participants must attend all study visits and agree to maintain their hairstyle and tolerate injections. The total study duration is one year, with multiple follow-up assessments.
CONDITIONS
Brief Title
Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with androgenic alopecia
- On a stable course of minoxidil (oral or topical) and/or 5-alpha reductase inhibitors for at least 12 months prior to baseline
- Female subjects must not have used hair growth medications or topicals for at least 6 months prior to baseline
- Willing to maintain current hair style during the study
- Able and willing to tolerate multiple scalp injections
- Able to attend all study-related clinical visits
- Willing to have small UV or red tattoo dots applied to the scalp to mark treatment areas
- Competent and willing to provide written informed consent
You will not qualify if you...
- Diagnosis of alopecia areata or other non-androgenic alopecia forms
- Active scalp skin diseases such as psoriasis or severe seborrheic dermatitis
- Scalp infection or cuts/abrasions on the scalp
- Severe active systemic infection
- History of surgical hair restoration within the last 12 months
- Current or recent malignancy within 5 years (except basal or squamous cell skin cancers)
- History of systemic chemotherapy or radiation
- History of thyroid dysfunction or autoimmune disorders (e.g., Graves disease, Hashimoto thyroiditis, systemic lupus erythematosus)
- Continuous daily use of NSAIDs or Vitamin E unless discontinued 7 days before first treatment
- Use of medications causing drug-induced hair loss within last 3 months
- Known allergy or sensitivity to tattoo ink
- Current anticoagulant therapy
- Significant tendency to develop keloids or hypertrophic scarring
- Unable to communicate with study staff
- Any health condition deemed by investigator to preclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive injections of either autologous hair follicle-derived secretome or placebo saline to affected scalp areas to stimulate hair regrowth.
6 injection visits on Day 0, Day 30, Day 90, Day 180, Day 270, and Day 365
Trial Site Locations
Total: 1 location
1
Ziering Medical
West Hollywood, California, United States, 90069
Actively Recruiting
Research Team
L
Lisa M Campbell, PhD
H
Heather Dwyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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