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

Not Applicable

• Conditions: Skin Cancer
• Interventions: Device: Fractional Laser and Chemical Peel

• Registration Number: NCT03775031
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-13
• Study Start: 2019-12-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
25% TCA Peel	Fractional Laser and Chemical Peel	25% TCA on 5 x 5 cm of sun exposed back
Fraxel 1927nm	Fractional Laser and Chemical Peel	Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes
Control	Fractional Laser and Chemical Peel	Patient serves as their own control
Fraxel 1550nm	Fractional Laser and Chemical Peel	Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes

Primary Outcome Measures

Name	Time	Method
IGF-1 Levels	3 months	To quantify IGF-1 levels in skin

Trial Locations

Locations (1)

Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin; 🇺🇸 Boston, Massachusetts, United States