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

NCT ID: NCT03775031

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-07-01

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.

Conditions

Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fraxel 1927nm

Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes

Group Type: ACTIVE_COMPARATOR

Fractional Laser and Chemical Peel

Intervention Type: DEVICE

Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

Fraxel 1550nm

Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes

Group Type: ACTIVE_COMPARATOR

Fractional Laser and Chemical Peel

Intervention Type: DEVICE

Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

25% TCA Peel

25% TCA on 5 x 5 cm of sun exposed back

Group Type: ACTIVE_COMPARATOR

Fractional Laser and Chemical Peel

Intervention Type: DEVICE

Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

Control

Patient serves as their own control

Group Type: PLACEBO_COMPARATOR

Fractional Laser and Chemical Peel

Intervention Type: DEVICE

Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

Interventions

Fractional Laser and Chemical Peel

Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Molly A. Wanner, MD

Dermatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Molly Wanner, MD

Role: CONTACT

mwanner@mgh.harvard.edu

617-726-5066

Facility Contacts

Molly Wanner

Role: primary

harvardskinstudies@partners.org

617-726-5066

Other Identifiers

2018P001770

Identifier Type: -

Identifier Source: org_study_id