Reduction in Symptoms After Laser Therapy With Acorn aHFS

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Other: autologous hair follicle derived secretome

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3R0M3
      • Rejuuv Medi Spa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects are healthy adults receiving laser skin rejuvenation therapy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Acorn Biolabs Inc.
• Investigators: Study Director: Lisa Campbell, PhD, Acorn Biolabs Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: skin, aging, rejuvenation, laser resurfacing, autologous secretome
• Other Study ID Numbers: 23-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No