Trials / Active Not Recruiting
Active Not RecruitingNCT03057964
PDL and Fractional Photothermolysis for Postsurgical Scars
The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis. Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design. The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. This study is a pilot study designed to determine feasibility of this procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PDL (Pulsed Dye Laser) | For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. |
| DEVICE | Fractional Photothermolysis Laser | For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis. |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2017-02-20
- Last updated
- 2025-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03057964. Inclusion in this directory is not an endorsement.