Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures

NCT06477172 | Recruiting

• 1 other identifier: ACN-101
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 40

Brief Summary

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

Conditions

Post Procedural Erythema

Outcome Measures

Primary Outcomes (2)

• Post-Procedure Symptoms

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male and Female
• Ages: 18-60
• Any Fitzpatrick skin type
• Planning a medical aesthetic procedure
• For subjects receiving hair procedures (closed to enrollment):
• Androgenic alopecia
• Traction alopecia
• Scarring alopecia
• 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.
• 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:
• Laser resurfacing of the face (ablative or non-ablative) or Ellacor of the face (Ellacor closed to enrollment)
• Tixel of the face
• Keralase of the scalp (scalp treatment closed to enrollment)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorn Biolabs Inc.: lead

Study Sites (40)

Skin Wellness Dermatology

Birmingham, Alabama, 35209, United States

WITHDRAWN

BelleSante

Scottsdale, Arizona, 85260, United States

RECRUITING

Arash Moradzadeh MD

Beverly Hills, California, 90210, United States

WITHDRAWN

Glenn Vallecillos, MD Inc

Beverly Hills, California, 90210, United States

WITHDRAWN

Behr Laser & Skin Care Center

Fresno, California, 93720, United States

RECRUITING

Aesthetics By Dr. Lee

Granite Bay, California, 95746, United States

RECRUITING

Carlo Honrado, MD, FACS

Los Angeles, California, 90067, United States

RECRUITING

Marcus Medical

Manhattan Beach, California, 90266, United States

WITHDRAWN

N2 Aesthetics

Manhattan Beach, California, 90266, United States

RECRUITING

Marina Plastic Surgery

Marina del Rey, California, 90292, United States

RECRUITING

M Beauty by Tess

San Diego, California, 92126, United States

RECRUITING

Modern Aesthetics

Walnut Creek, California, 94598, United States

WITHDRAWN

Dr. Christie

West Hollywood, California, 90069, United States

COMPLETED

Ziering Medical

West Hollywood, California, 90069, United States

RECRUITING

BEAUTY by BUFORD

Lone Tree, Colorado, 80124, United States

COMPLETED

Bauman Medical

Boca Raton, Florida, 33432, United States

RECRUITING

Mirror Plastic Surgery

St. Petersburg, Florida, 33701, United States

RECRUITING

Hive Aesthetic LLC

Chicago, Illinois, 60657, United States

RECRUITING

Chernoff Cosmetic Surgery

Indianapolis, Indiana, 46220, United States

RECRUITING

ICON Antiaging & Aesthetics

Birmingham, Michigan, 48009, United States

WITHDRAWN

Davis Cosmetic Plastic Surgery

Cherry Hill, New Jersey, 08003, United States

COMPLETED

AIEREM Aesthetics Spa & Plastic Surgery

Manhattan, New York, 75231, United States

RECRUITING

Lewis Dermatology and Associates

New York, New York, 10021, United States

RECRUITING

Unger Medical Hair Transplant Clinic

New York, New York, 10021, United States

ACTIVE NOT RECRUITING

SkinLabRx

New York, New York, 10028, United States

COMPLETED

Sadick Dermatology

New York, New York, 10075, United States

NOT YET RECRUITING

AIEREM Aesthetics Spa & Plastic Surgery

Syosset, New York, 11791, United States

RECRUITING

Austin Plastic Surgeon

Austin, Texas, 78758, United States

RECRUITING

Dallas Plastic Surgery Institute

Dallas, Texas, 75225, United States

RECRUITING

US Dermatology Partners / Dermatology Associates of Tyler

Tyler, Texas, 75703, United States

RECRUITING

AG Aesthetic Centre

Vancouver, Washington, 98660, United States

RECRUITING

Dr. Jean Carruthers Cosmedic

Vancouver, British Columbia, V5Z 4E1, Canada

RECRUITING

Dr. Amber Bocknek

Aurora, Ontario, L4G1B9, Canada

RECRUITING

Sanjeev Goel MD Peak Human

Brampton, Ontario, L6W 3E1, Canada

COMPLETED

Compass Dermatology

Toronto, Ontario, M4S 2N5, Canada

ACTIVE NOT RECRUITING

Rejuuv

Toronto, Ontario, M5R 0C7, Canada

RECRUITING

Dr. Nowell Solish Cosmetic Dermatologist

Toronto, Ontario, M5R 3N8, Canada

RECRUITING

FCP Dermatology

Toronto, Ontario, M5X 1A9, Canada

WITHDRAWN

BeSpoke Wellness

Toronto, Ontario, Canada

COMPLETED

Clinique Antiaging

Montreal, Quebec, H3A 1S2, Canada

RECRUITING

Study Officials

• Drew Taylor, PhD

  Acorn Biolabs

  STUDY CHAIR

Central Study Contacts

Lisa Campbell, PhD

CONTACT

858-997-7447; lisa.campbell@acorn.me

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); CA (9)