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

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ClinicalTrials.gov Identifier: NCT03775031
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Molly A. Wanner, MD, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Skin Cancer Device: Fractional Laser and Chemical Peel Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized-Controlled (Subjects will serve as their own control)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fraxel 1927nm
Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes
 Device: Fractional Laser and Chemical Peel
Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Active Comparator: Fraxel 1550nm
Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes
 Device: Fractional Laser and Chemical Peel
Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Active Comparator: 25% TCA Peel
25% TCA on 5 x 5 cm of sun exposed back
 Device: Fractional Laser and Chemical Peel
Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
Placebo Comparator: Control
Patient serves as their own control
 Device: Fractional Laser and Chemical Peel
Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel


Outcome Measures
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Primary Outcome Measures :
  1. IGF-1 Levels [ Time Frame: 3 months ]
    To quantify IGF-1 levels in skin


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775031


Contacts
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Contact: Molly Wanner, MD 617-726-5066 mwanner@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin Recruiting
Boston, Massachusetts, United States, 02114
Contact: Molly Wanner    617-726-5066    harvardskinstudies@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Responsible Party: Molly A. Wanner, MD, Dermatologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03775031    
Other Study ID Numbers: 2018P001770
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases