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

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

Detailed Description
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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.

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

Conditions
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Skin Cancer

Intervention / Treatment
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* Device: Fractional Laser and Chemical Peel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized-Controlled (Subjects will serve as their own control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fraxel 1927nm<br>Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes | Device: Fractional Laser and Chemical Peel<br>* Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel<br>|
| Active Comparator: Fraxel 1550nm<br>Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes | Device: Fractional Laser and Chemical Peel<br>* Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel<br>|
| Active Comparator: 25% TCA Peel<br>25% TCA on 5 x 5 cm of sun exposed back | Device: Fractional Laser and Chemical Peel<br>* Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel<br>|
| Placebo Comparator: Control<br>Patient serves as their own control | Device: Fractional Laser and Chemical Peel<br>* Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 Levels | To quantify IGF-1 levels in skin | 3 months |