RecruitingNCT06477172
Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
A Multi-site, Prospective, Observational Study of Autologous Hair Follicle Secretome (aHFS) as an Adjunct to Medical Aesthetic Procedures
Sponsor
Acorn Biolabs Inc.
Enrollment
500 participants
Start Date
Sep 9, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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.
- Planning to use Acorn Autologous Hair Follicle Secretome cosmetic product
Exclusion Criteria6
- 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
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Locations(40)
View Full Details on ClinicalTrials.gov
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NCT06477172