PDL and Fractional Photothermolysis for Postsurgical Scars

Scar Clinical Trial

Official title:

The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03057964
• Other study ID #: STU00204024
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females = 18 years old

2. Fitzpatrick skin types I-VI

3. Subjects are in good health as judged by the investigator.

4. Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks.

5. Subjects applying topical retinoids, must discontinue one week prior to treatment.

6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

1. History of recurrent facial or labial herpes simplex infection

2. Subjects applying topical retinoids, must discontinue one week prior to treatment.

3. Subjects with a history of hypertrophic scars or keloids

4. Pregnant or breast feeding

5. Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

6. Subjects who are unable to understand the protocol or give informed consent.

7. Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.

Related Conditions & MeSH terms

• Scar

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score of Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as "not at all" or "normal skin" and 10 as "very much so" or "very different".	Baseline and 6 Months