PDL and Fractional Photothermolysis for Postsurgical Scars

• ClinicalTrials.gov Identifier: NCT03057964
• Recruitment Status: Enrolling by invitation
• First Posted: February 20, 2017
• Last Update Posted: May 8, 2020
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Murad Alam, Northwestern University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Scar	Device: PDL (Pulsed Dye Laser); Device: Fractional Photothermolysis Laser	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
• Actual Study Start Date: March 1, 2017
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: PDL (Pulsed Dye Laser) and Fractional Photothermolysis	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.; Other Name: Pulsed Dye Laser; 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.; Other Name: Fraxel Laser
No Intervention: Control

Outcome Measures

Primary Outcome Measures :

1. Change in score of Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Baseline and 6 Months ]
   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".

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD; Northwestern University

More Information

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT03057964
• Other Study ID Numbers: STU00204024
• First Posted: February 20, 2017
• Last Update Posted: May 8, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cicatrix; Fibrosis; Pathologic Processes