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

Primary Purpose

Skin Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fractional Laser and Chemical Peel

About this trial

This is an interventional prevention trial for Skin Cancer

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fraxel 1927nm

Fraxel 1550nm

25% TCA Peel

Control

Arm Description

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

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

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

Patient serves as their own control

Outcomes

Primary Outcome Measures

IGF-1 Levels

To quantify IGF-1 levels in skin

Secondary Outcome Measures

Full Information

NCT ID

NCT03775031

First Posted

December 12, 2018

Last Updated

October 19, 2020

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03775031

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

July 1, 2021 (Anticipated)

Study Completion Date

July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fraxel 1927nm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fraxel 1550nm

Arm Type

Active Comparator

Arm Description

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

Arm Title

25% TCA Peel

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Patient serves as their own control

Intervention Type

Device

Intervention Name(s)

Fractional Laser and Chemical Peel

Intervention Description

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

Primary Outcome Measure Information:

Title

IGF-1 Levels

Description

To quantify IGF-1 levels in skin

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Molly Wanner, MD

Phone

617-726-5066

mwanner@mgh.harvard.edu

Facility Information:

Facility Name

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

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Molly Wanner

Phone

617-726-5066

harvardskinstudies@partners.org

12. IPD Sharing Statement

Plan to Share IPD

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

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