Chemical Peels and Fractional Laser on IGF-1 Levels in Skin

Overview

The purpose of this study is to evaluate the impact of fractional laser versus chemical peels on IGF-1 levels in skin.

Full Title of Study: “Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2021

Detailed Description

This study is designed to assess the feasibility of using a fractional non ablative laser and chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that fractional non ablative laser and a TCA chemical peel can induce similar effects as the fractional ablative laser at three months. In other words, our theory is that these approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair and response mechanisms.

Interventions

  • Device: Fractional Laser and Chemical Peel
    • Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

Arms, Groups and Cohorts

  • Active Comparator: Fraxel 1927nm
    • Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes
  • Active Comparator: Fraxel 1550nm
    • Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes
  • Active Comparator: 25% TCA Peel
    • 25% TCA on 5 x 5 cm of sun exposed back
  • Placebo Comparator: Control
    • Patient serves as their own control

Clinical Trial Outcome Measures

Primary Measures

  • IGF-1 Levels
    • Time Frame: 3 months
    • To quantify IGF-1 levels in skin

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female subjects >55 years old – Fitzpatrick type I-II – Able to provide informed consent. – Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix). Exclusion Criteria:

  • Prior laser or peel treatment in the area evaluated in the current study in the past year. – Currently taking immunosuppressant medications known to interfere wound healing or anti-inflammatory medications (such as NSAIDs, or steroids). – Subjects who have underlying diseases that could alter wound healing response (such as Diabetes). – Currently taking insulin. – History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study. – History of abnormal scarring such as Keloids. – History of vitiligo. – Allergy or sensitivity or allergy to topical anesthesia – Inability to use sunscreen. – History of smoking in the last 10 years – Scar or prior surgery in the area of treatment. – Use of isotretinoin in the prior 6 months – Subjects who have bleeding disorders or who are taking anticoagulants

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Molly A. Wanner, MD, Dermatologist – Massachusetts General Hospital
  • Overall Contact(s)
    • Molly Wanner, MD, 617-726-5066, mwanner@mgh.harvard.edu

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