NCT05363969

Brief Summary

Treatment of self harm scars with fractionated laser.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

April 21, 2022

Last Update Submit

May 3, 2022

Conditions

Self Harm

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Interventions

Fractionated laser resurfacingDEVICE

Patients will receive 3-4 treatments with fractionated laser resurfacing

Also known as: Fraxel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self harm scars

You may not qualify if:

  • Active self harm behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman Dept of Dermatology

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 6, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

May 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share