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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03775031
• Other study ID #: 2018P001770
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: Molly Wanner, MD
• Phone: 617-726-5066
• Email: mwanner[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-1 Levels	To quantify IGF-1 levels in skin	3 months