Recruiting

Chemical Peels & Fractional Laser

Sponsor:

Massachusetts General Hospital

Code:

NCT03775031

Conditions

Skin Cancer

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Fractional Laser and Chemical Peel

Study Details

Brief summary:

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

Conditions

Skin Cancer

Study ID

NCT03775031

Start date

Dec 1, 2019

Status verified date

Oct, 2020

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Fractional Laser and Chemical Peel

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

Primary outcome measure

  • IGF-1 Levels [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Molly Wanner, MD

617-726-5066mwanner@mgh.harvard.edu

Locations

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

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Molly Wanner

617-726-5066harvardskinstudies@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 22, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2020-10-22.