Striae Distensae Treatment Using Deep Skin Abrasion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Striae Distensae Treatment Device.
- Who it may be relevant to
- Registry conditions: Striae Distensae. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Stretch Mark Treatment Using Subcutaneous Skin Abrasion
Overview
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: 1. Does the device improve the appearance of striae distensae? 2. 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: 1. Undergo treatment with the device in the clinic 2. 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.
Interventions
- Device Striae Distensae Treatment Device
One time deep skin treatment
Primary outcome measures
- Improvement in Striae Distensae Appearance [Time frame: From enrollment to 12 months after treatment]
Eligibility criteria
Inclusion criteria
- Striae distensae
Exclusion criteria
- Smoking
- coagulation deficiency
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT07087405 · IRB-P00051021