NCT Number: NCT06477172
Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Dr. Jean Carruthers Cosmedic, Vancouver, British Columbia, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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):
- 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 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
Treatment and study plan
Primary outcomes
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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.
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Acorn Biolabs Inc.
Industry
Registry information
Official study title
A Multi-site, Prospective, Observational Study of Autologous Hair Follicle Secretome (aHFS) as an Adjunct to Medical Aesthetic Procedures
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 27, 2024
- Registry last updated
- Mar 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.