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

Mass General Brigham

Status: Unknown

Conditions: Skin Cancer

Treatments: Device: Fractional Laser and Chemical Peel

Study type: Interventional

Funder types: Other

Identifiers

NCT03775031

2018P001770

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups, including a placebo group

Fraxel 1927nm

Active Comparator group

Description:

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

Treatment:

Device: Fractional Laser and Chemical Peel

Fraxel 1550nm

Active Comparator group

Description:

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

Treatment:

Device: Fractional Laser and Chemical Peel

25% TCA Peel

Active Comparator group

Description:

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

Treatment:

Device: Fractional Laser and Chemical Peel

Control

Placebo Comparator group

Description:

Patient serves as their own control

Treatment:

Device: Fractional Laser and Chemical Peel