Post Procedural Erythema
Conditions
Brief summary
Non-interventional, multi-site, prospective, open-label, observational, real-world study of autologous hair follicle secretome use.
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.
Interventions
None listed
Sponsors
Acorn Biolabs Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedure Symptoms | 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. |
| Downtime Questionnaire | 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. |
Countries
Canada, United States
Contacts
CONTACTLisa Campbell, PhD
STUDY_CHAIRDrew Taylor, PhD
Acorn Biolabs
Outcome results
None listed