Back to resultsTreatment of Self Harm Scars With Fraxel Laser
Primary Purpose
Self Harm
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractionated laser resurfacing
Sponsored by
About this trial
This is an interventional treatment trial for Self Harm
Eligibility Criteria
Inclusion Criteria:
- Self harm scars
Exclusion Criteria:
- Active self harm behaviors
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical improvement of scars
Patients will be assessed with pre and post treatment photography. Photographs will be taken at baseline and 1 month after the final treatment. After the final treatment both the investigator and patients will rate appearance of scarring as "worsened", "unchanged" or "improved" as compared to baseline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05363969
Brief Title
Treatment of Self Harm Scars With Fraxel Laser
Official Title
Treatment of Self Harm Scars With Fraxel Laser
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Darius Mehregan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of self harm scars with fractionated laser.
Detailed Description
Fractionated resurfacing lasers have been shown to be useful for scars including acne scars, burns scars and striae. We will treat self harm scars with 3 to 4 treatments using a "Fraxel" fractionated laser. Patients will be screened to ensure they are not actively engaged in self harm behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Fractionated laser resurfacing
Other Intervention Name(s)
Fraxel
Intervention Description
Patients will receive 3-4 treatments with fractionated laser resurfacing
Primary Outcome Measure Information:
Title
Clinical improvement of scars
Description
Patients will be assessed with pre and post treatment photography. Photographs will be taken at baseline and 1 month after the final treatment. After the final treatment both the investigator and patients will rate appearance of scarring as "worsened", "unchanged" or "improved" as compared to baseline.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self harm scars
Exclusion Criteria:
Active self harm behaviors
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Self Harm Scars With Fraxel Laser
We'll reach out to this number within 24 hrs