Stretch Mark Treatment Using Subcutaneous Skin Abrasion
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Boston Children's Hospital
- Enrollment
- 10
- Primary Endpoint
- Improvement in Striae Distensae Appearance
Overview
Brief Summary
The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are:
- Does the device improve the appearance of striae distensae?
- Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device.
Participants will:
- Undergo treatment with the device in the clinic
- Visit the clinic 1 week, 3 months, and 1 year for checkups and tests
Detailed Description
Participants will have the area of striae distensae anesthetized with local anesthetic. A biopsy will be performed and a device will be placed underneath the skin that will abrade the skin. Three months later another biopsy will be performed, photographs will be taken, and participants will fill out surveys to determine the effectiveness of the device to improve the appearance of the striae distensae.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Striae distensae
Exclusion Criteria
- •Smoking, coagulation deficiency
Outcomes
Primary Outcomes
Improvement in Striae Distensae Appearance
Time Frame: From enrollment to 12 months after treatment
Comparison of photographs before and after treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Arin Greene
Professor of Surgery
Boston Children's Hospital