Reduction in Symptoms After Laser Therapy With Acorn aHFS

NCT06336135 — Completed, 11 participants, Acorn Biolabs Inc.

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

Registry	NCT06336135
Status	Completed
Study type	Observational
Enrollment	11 (Actual)
Sponsor	Acorn Biolabs Inc. (Industry)
Conditions	Skin Aging
Interventions	autologous hair follicle derived secretome (Other)
Dates	start 2024-03-25, primary completion 2025-12-02, completion 2025-12-02, first posted 2024-03-28, last updated 2025-12-12
Locations	1 site in Canada

-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.

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+Arms and interventions

autologous hair follicle derived secretome (Other), also known as Acorn autologous hair follicle secretome, aHFS: 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.

+Outcome measures

Primary outcomes

Reduction in severity and duration of symptoms [2 weeks]: Each region of interest will be evaluated daily for the severity and duration of eight symptoms

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Rejuuv Medi Spa	Markham, Ontario	Canada

+Investigators

Lisa Campbell, PhD, Study director, Acorn Biolabs Inc.