Actively Recruiting
Blinded, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Autologous Hair Follicle Secretome for Facial Rejuvenation
Led by Acorn Biolabs Inc. · Updated on 2026-05-04
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an autologous hair follicle secretome treatment for facial rejuvenation in adults aged 30 to 70 years. This randomized, placebo-controlled trial includes double-blind and open-label extension phases to compare the secretome against saline injections. The secretome contains growth factors and other molecules derived from cultured hair follicles and aims to improve skin quality for individuals with moderate to very severe facial aging. The treatment involves collecting 50 to 75 hair follicles by plucking, selecting ten follicles for culture over four weeks, and then preparing a lyophilized secretome product. Participants receive intradermal injections of secretome diluted with saline under the eyes and across the face at specified points using a MicronJet 800 needle to ensure precise delivery. Control participants receive saline injections following the same injection pattern. The study includes up to 120 days of double-blind treatment with an optional open-label extension for control participants to receive the active treatment. During the trial, participants undergo assessments at baseline and at 30, 60, 90, and 120 days to measure skin quality using the VISIA-CR system and report their satisfaction with the treatment. Researchers also monitor for treatment-emergent adverse events. Participants must follow specific skincare routines, avoid other cosmetic procedures, and minimize sun exposure throughout the study. The total participation time covers the 120-day treatment period plus follow-up visits to evaluate outcomes and safety.
CONDITIONS
Brief Title
Secretome Treatment for Facial Rejuvenation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 30 to 75 years at consent
- Fitzpatrick skin types I to V
- Moderate to very severe facial aging in elasticity, wrinkles, and skin roughness
- Willing to avoid cosmetic procedures during the study
- Willing to use provided skincare products as directed and not add new products
- Male subjects with facial hair willing to shave on treatment days
- Willing to minimize sun exposure and follow sun protection measures
- Able to provide informed consent and tolerate multiple injections
- Negative urine pregnancy test if applicable
- Female participants of childbearing potential must use accepted birth control consistently
You will not qualify if you...
- Use of certain topical treatments on the face within 4 weeks prior and during the study
- Dermatologic conditions in the treatment area that could interfere with results
- Starting or stopping GLP-1 agonists or planned weight changes during study
- History of keloid formation or abnormal wound healing
- Recent medical aesthetic treatments on the face within specified timeframes
- Use of neuromodulators or dermal fillers within specified months prior
- Use of other anti-aging treatments that may affect study results
- Heavy smoking (more than 1 pack per day)
- Energy-based device treatments in the area within 6 months
- Current isotretinoin use
- Immunosuppressant use or autoimmune conditions except stable Hashimoto's
- Recent facial surgeries within 12 months
- Participation in other investigational studies within 30 days
- Severe active infections
- Recent malignancy or cancer treatments within 5 years
- Continuous use of NSAIDs or Vitamin E unless stopped before treatment
- Pregnancy or trying to become pregnant within a year
- Current anticoagulant therapy excluding low dose aspirin or omega-3
- Any other condition judged by the investigator to pose risk or confound results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 120 days
Participants receive intradermal injections of either the autologous hair follicle secretome or placebo saline for facial rejuvenation.
5 visits (at baseline, 30, 60, 90, and 120 days)
Duration - up to 120 days
Participants in the control group have the option to cross over to receive active secretome treatment in an open-label extension phase.
Additional visits as per treatment schedule
Trial Site Locations
Total: 1 location
1
Steve Yoelin, MD
Newport Beach, California, United States, 92663
Actively Recruiting
Research Team
L
Lisa M Campbell, PhD
H
Heather Dwyer, MSc, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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