Reduction in Symptoms After Laser Therapy With Acorn aHFS

March 22, 2024 updated by: Acorn Biolabs Inc.

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

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in severity and duration of symptoms
Time Frame: 2 weeks
Each region of interest will be evaluated daily for the severity and duration of eight symptoms
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorn Biolabs Inc.

Investigators

  • Study Director: Liis Teene, Acorn Biolabs Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 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)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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