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NCT06336135 Clinical Trial

Reduction in Symptoms After Laser Therapy With Acorn aHFS

Skin Aging Clinical Trial

Official title:
A Prospective, Single-blind, Randomized, Placebo-controlled, Clinical Trial Evaluating Reduction in Severity and Duration of Symptoms After Laser Therapy With Acorn aHFS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06336135
Other study ID # 23-001
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 25, 2024
Est. completion date December 2025

Study information
Verified date March 2024
Source Acorn Biolabs Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the severity and duration of symptoms experienced after laser therapy comparing four post-procedure topical products. Each product is applied to an individual region of interest (5 cm diameter) on the back or décolleté according to randomization code after laser therapy. The subject, blind to the product applied to each of 4 regions of interest, assesses eight symptoms daily for 14 days. Photography is performed daily.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date December 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Male or Female - Age: =18 and =60 years - Any skin tone Fitzpatrick score 1-2 (light), 3-4 (medium), 5-6 (dark) - Competent and willing to provide written, informed consent to participate in all study activities Exclusion Criteria: - Pregnant women - Are participating/have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by Sponsor - Use of retinoids 7 days prior to the procedure - Active cutaneous infections in the treatment area - Diseases that could inhibit healing, such as scleroderma, or other cutaneous conditions that could confound study results - Subjects unable to communicate with the investigator and staff - Any health condition that in the investigator's opinion should preclude participation in this study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• autologous hair follicle derived secretome
aHFS is a cosmetic topical intended to be applied to the human body after skin resurfacing cosmetic procedures. aHFS is produced from the plucked hair follicles of each individual, making it autologous.

Locations
Country Name City State
Canada Rejuuv Medi Spa Markham Ontario

Sponsors (1)
Lead Sponsor Collaborator
Acorn Biolabs Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in severity and duration of symptoms Each region of interest will be evaluated daily for the severity and duration of eight symptoms 2 weeks
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