Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures

March 2, 2026 updated by: Acorn Biolabs Inc.

A Multi-site, Prospective, Observational Study of Autologous Hair Follicle Secretome (aHFS) as an Adjunct to Medical Aesthetic Procedures

Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This non-interventional, observation study is to collect real-world data on the use of an autologous, hair follicle derived secretome topical cosmetic product following various medical aesthetic procedures.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Recruiting
        • Dr. Jean Carruthers Cosmedic
        • Contact:
        • Principal Investigator:
          • Jean Carruthers, MD, FRCSC, FRC (OPHTH)
    • Ontario
      • Aurora, Ontario, Canada, L4G1B9
        • Recruiting
        • Dr. Amber Bocknek
        • Contact:
        • Principal Investigator:
          • Amber Bocknek, MD
      • Brampton, Ontario, Canada, L6W 3E1
        • Completed
        • Sanjeev Goel MD Peak Human
      • Toronto, Ontario, Canada, M5R 0C7
      • Toronto, Ontario, Canada, M5R 3N8
        • Recruiting
        • Dr. Nowell Solish Cosmetic Dermatologist
        • Contact:
        • Principal Investigator:
          • Nowell Solish, MD
      • Toronto, Ontario, Canada, M4S 2N5
        • Active, not recruiting
        • Compass Dermatology
      • Toronto, Ontario, Canada, M5X 1A9
        • Withdrawn
        • FCP Dermatology
      • Toronto, Ontario, Canada
        • Completed
        • BeSpoke Wellness
    • Quebec
      • Montreal, Quebec, Canada, H3A 1S2
        • Recruiting
        • Clinique Antiaging
        • Contact:
        • Principal Investigator:
          • Cynthia Stolovitz, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Withdrawn
        • Skin Wellness Dermatology
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • BelleSante
        • Contact:
        • Principal Investigator:
          • Kristine Romine, MD, FAAD
    • California
      • Beverly Hills, California, United States, 90210
        • Withdrawn
        • Arash Moradzadeh MD
      • Beverly Hills, California, United States, 90210
        • Withdrawn
        • Glenn Vallecillos, MD Inc
      • Fresno, California, United States, 93720
        • Recruiting
        • Behr Laser & Skin Care Center
        • Contact:
        • Principal Investigator:
          • Kathleen Behr, MD
        • Sub-Investigator:
          • Mansee Desai, MD
        • Sub-Investigator:
          • Regine Mathieu, MD
        • Contact:
      • Granite Bay, California, United States, 95746
        • Recruiting
        • Aesthetics By Dr. Lee
        • Principal Investigator:
          • Luis Lee, MD
        • Contact:
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Carlo Honrado, MD, FACS
        • Principal Investigator:
          • Carlo Honrado, MD, FACS
        • Contact:
      • Manhattan Beach, California, United States, 90266
        • Recruiting
        • N2 Aesthetics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicola Lowrey, MPAP PA-C
      • Manhattan Beach, California, United States, 90266
        • Withdrawn
        • Marcus Medical
      • Marina del Rey, California, United States, 90292
        • Recruiting
        • Marina Plastic Surgery
        • Principal Investigator:
          • Justin Perez, MD
      • San Diego, California, United States, 92126
        • Recruiting
        • M Beauty by Tess
        • Contact:
        • Principal Investigator:
          • Tess Mauricio, MD
      • Walnut Creek, California, United States, 94598
        • Withdrawn
        • Modern Aesthetics
      • West Hollywood, California, United States, 90069
        • Recruiting
        • Ziering Medical
        • Contact:
        • Principal Investigator:
          • Craig L. Ziering, DO FAOCD FISHRS
      • West Hollywood, California, United States, 90069
        • Completed
        • Dr. Christie
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Completed
        • Beauty by Buford
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Recruiting
        • Bauman Medical
        • Contact:
        • Principal Investigator:
          • Alan J. Bauman, MD
        • Sub-Investigator:
          • Shiwei Han, MD
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Mirror Plastic Surgery
        • Principal Investigator:
          • Akash Chandawarkar, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Hive Aesthetic LLC
        • Contact:
        • Principal Investigator:
          • Christopher Rosenbarger, PA-C
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46220
        • Recruiting
        • Chernoff Cosmetic Surgery
        • Contact:
        • Principal Investigator:
          • Gregory Chernoff, MD
    • Michigan
      • Birmingham, Michigan, United States, 48009
        • Withdrawn
        • ICON Antiaging & Aesthetics
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Completed
        • Davis Cosmetic Plastic Surgery
    • New York
      • Manhattan, New York, United States, 75231
        • Recruiting
        • AIEREM Aesthetics Spa & Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Eunice Park, MD
        • Sub-Investigator:
          • Shirley Hu, MD
      • New York, New York, United States, 10021
        • Recruiting
        • Lewis Dermatology and Associates
        • Principal Investigator:
          • Amy Lewis, MD
      • New York, New York, United States, 10075
        • Not yet recruiting
        • Sadick Dermatology
        • Principal Investigator:
          • Neil Sadick, MD
        • Contact:
      • New York, New York, United States, 10021
        • Active, not recruiting
        • Unger Medical Hair Transplant Clinic
      • New York, New York, United States, 10028
        • Completed
        • SkinLabRx
      • Syosset, New York, United States, 11791
        • Recruiting
        • AIEREM Aesthetics Spa & Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Eunice Park, MD
        • Sub-Investigator:
          • Shirley Hu, MD
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • Austin Plastic Surgeon
        • Contact:
        • Principal Investigator:
          • Johnny Franco, MD
      • Dallas, Texas, United States, 75225
        • Recruiting
        • Dallas Plastic Surgery Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Weir, MSN, APRN, NP-C
      • Tyler, Texas, United States, 75703
        • Recruiting
        • US Dermatology Partners / Dermatology Associates of Tyler
        • Principal Investigator:
          • Jennifer D Holman, MD
    • Washington
      • Vancouver, Washington, United States, 98660
        • Recruiting
        • AG Aesthetic Centre
        • Principal Investigator:
          • Allen Gabriel, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients planning a medical aesthetic procedure and use of Autologous Hair Follicle Secretome cosmetic post-procedure.

Description

Inclusion Criteria:

  • Male and Female
  • Ages: 18-60
  • Any Fitzpatrick skin type
  • Planning a medical aesthetic procedure

  • For subjects receiving hair procedures (closed to enrollment):

    1. Androgenic alopecia
    2. Traction alopecia
    3. Scarring alopecia
    4. Stable use of any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to enrollment in the study is allowed.
    5. No intention to start new hair growth medications or change dose of hair growth medications from the time of consent through the end of the study follow-up period.

  • Undergoing one of the following medical aesthetic procedures:

    1. Laser resurfacing of the face (ablative or non-ablative) or Ellacor of the face (Ellacor closed to enrollment)
    2. Tixel of the face
    3. Keralase of the scalp (scalp treatment closed to enrollment)
    4. Acne Scars and Surgery scars, either old or new as long as old scars are also being treated with ablative or non-ablative laser or microneedling (e.g. abdominoplasty, breast reduction/ reconstruction/enhancement, post-weight loss, etc.
  • Planning to use Acorn Autologous Hair Follicle Secretome cosmetic product

Exclusion Criteria:

  • Pregnant or Breastfeeding
  • Participation in an interventional clinical trial in the last 30 days
  • Use of other topical cosmetic products that may confound results
  • Use of retinoids within 7 days prior to facial procedure
  • For those receiving hair treatment, must not have had a hair transplant in the treatment area within the past 12 months
  • Any health condition that in the investigator's opinion should preclude participation in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Procedure Symptoms
Time Frame: 1-7 days
Symptoms of redness, swelling, oozing, pain, tenderness, crusting, itching and discoloration will be measured using a 1-10 likert scale with 0 being best possible and 10 being worst imaginable.
1-7 days
Downtime Questionnaire
Time Frame: 1-7 days
Questionnaire asking what activities would they have done, if it were not for their face appearance. Date of end of downtime captured.
1-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorn Biolabs Inc.

Investigators

  • Study Chair: Drew Taylor, PhD, Acorn Biolabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACN-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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