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

NCT03775031 | Unknown

• 1 other identifier: 2018P001770
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• IGF-1 Levels

  To quantify IGF-1 levels in skin

  3 months

Study Arms (4)

Fraxel 1927nm

ACTIVE COMPARATOR

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

Device: Fractional Laser and Chemical Peel

Fraxel 1550nm

ACTIVE COMPARATOR

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

Device: Fractional Laser and Chemical Peel

25% TCA Peel

ACTIVE COMPARATOR

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

Device: Fractional Laser and Chemical Peel

Control

PLACEBO COMPARATOR

Patient serves as their own control

Device: Fractional Laser and Chemical Peel

Interventions

Fractional Laser and Chemical Peel DEVICE

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

25% TCA Peel; Control; Fraxel 1550nm; Fraxel 1927nm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

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

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Chemexfoliation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Central Study Contacts

Molly Wanner, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Model Details: Randomized-Controlled (Subjects will serve as their own control)

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 13, 2018
• Study Start: December 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)