Clinical trial NCT06477172: Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures
Official title: A Multi-site, Prospective, Observational Study of Autologous Hair Follicle Secretome (aHFS) as an Adjunct to Medical Aesthetic Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Procedural Erythema
Lead sponsor: Acorn Biolabs Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients planning a medical aesthetic procedure and use of aHFS cosmetic post-procedure.

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.

Eligibility criteria: Inclusion Criteria:

* Male and Female,
* Ages: 18-60
* Any Fitzpatrick skin type
* Planning a medical aesthetic procedure
* Planning to use aHFS 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
* Any health condition that in the investigator's opinion should preclude participation in study

Primary outcomes:
measure: Post-Procedure Symptoms
timeFrame: 1-7 days
measure: Downtime Questionnaire
timeFrame: 1-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Skin Wellness Dermatology
state: Alabama
city: Scottsdale
country: United States
facility: BelleSante
state: Arizona
city: Beverly Hills
country: United States
facility: Glenn Vallecillos MD Inc
state: California
city: Beverly Hills
country: United States
facility: Jalalabadi Plastic Surgery
state: California
city: Beverly Hills
country: United States
facility: AM Facial Plastics
state: California
city: Newport Beach
country: United States
facility: Steve Yoelin, MD
state: California
city: Redondo Beach
country: United States
facility: Marcus Medical
state: California
city: West Hollywood
country: United States
facility: Dr. Christie
state: California
city: West Hollywood
country: United States
facility: Ziering Medical
state: California
city: Lone Tree
country: United States
facility: Beauty by Buford
state: Colorado
city: Boca Raton
country: United States
facility: Bauman Medical
state: Florida
city: Cherry Hill
country: United States
facility: Davis Cosmedic Plastic Surgery
state: New Jersey
city: New York
country: United States
facility: Luxurgery
state: New York
city: New York
country: United States
facility: Haideh Hirmand MD, Aesthetic Plastic Surgery
state: New York
city: Austin
country: United States
facility: Austin Plastic Surgeon
state: Texas
city: Vancouver
country: Canada
facility: Dr. Jean Carruthers Cosmedic
state: British Columbia
city: Brampton
country: Canada
facility: Sanjeev Goel, MD Peak Human
state: Ontario
city: Toronto
country: Canada
facility: Compass Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Rejuuv
state: Ontario
city: Toronto
country: Canada
facility: Dr. Nowell Solish Cosmetic Dermatologist
state: Ontario
city: Toronto
country: Canada
facility: FCP Dermatology
state: Ontario
city: Toronto
country: Canada
facility: The Toronto Hair Transplant Clinic
state: Ontario
city: Toronto
country: Canada
facility: BeSpoke Wellness
state: Ontario
city: Montreal
country: Canada
facility: Clinique Antiaging
state: Quebec
Study officials:
affiliation: Acorn Biolabs
name: Drew Taylor, PhD
role: STUDY_CHAIR
References: