Self HarmNCT05363969
Treatment of Self Harm Scars With Fraxel Laser
A study testing Fractionated laser resurfacing in people with Self Harm, run by Darius Mehregan.
Trial summary
Treatment of self harm scars with fractionated laser. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Self Harm
- What is being tested?
- Fractionated laser resurfacing
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self harm scars
Who cannot join
- Active self harm behaviors
About this study
Treatment of self harm scars with fractionated laser.
Read the 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.
- Conditions
- Self Harm
- Being tested
- Fractionated laser resurfacing
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated laser resurfacingDevice
Also called Fraxel
Patients will receive 3-4 treatments with fractionated laser resurfacing
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self HarmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Darius Mehregan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darius Mehregan, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363969
- Sponsor's protocol ID
- IRB-21-06-3672
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Self Harm Scars With Fraxel Laser
- ClinicalTrials.gov ID
- NCT05363969
- Acronym / sponsor ID
- IRB-21-06-3672
- Conditions
- Self Harm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Darius MehreganUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self harm scars
Key exclusion criteria (1 listed)
- Active self harm behaviors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractionated laser resurfacingAlso: FraxelPatients will receive 3-4 treatments with fractionated laser resurfacing | Device | – |
Primary outcome
Clinical improvement of scars
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated laser resurfacing in people with Self Harm, run by Darius Mehregan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement of scars (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.