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

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

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

Study Overview

• Status: Unknown
• Conditions: Skin Cancer
• Intervention / Treatment: Device: Fractional Laser and Chemical Peel

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin
      • Contact: Molly Wanner; Phone Number: 617-726-5066; Email: harvardskinstudies@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fraxel 1927nm; Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes	Device: Fractional Laser and Chemical Peel; Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Active Comparator: Fraxel 1550nm; Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes	Device: Fractional Laser and Chemical Peel; Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Active Comparator: 25% TCA Peel; 25% TCA on 5 x 5 cm of sun exposed back	Device: Fractional Laser and Chemical Peel; Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Placebo Comparator: Control; Patient serves as their own control	Device: Fractional Laser and Chemical Peel; Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGF-1 Levels	To quantify IGF-1 levels in skin	3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 2018P001770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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