PDL and Fractional Photothermolysis for Postsurgical Scars

NCT ID: NCT03057964

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PDL (Pulsed Dye Laser) and Fractional Photothermolysis

Group Type: EXPERIMENTAL

PDL (Pulsed Dye Laser)

Intervention Type: DEVICE

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

Intervention Type: DEVICE

For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Pulsed Dye Laser; Fraxel Laser

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Countries

United States

References

Kang BY, Ibrahim SA, Weil A, Reynolds KA, Johnson T, Wilson S, Lee MH, Kim JYS, Dirr MA, Poon E, Alam M. Treatment of Surgical Scars With Combination Pulsed Dye and Fractional Nonablative Laser: A Randomized Controlled Trial. Ann Surg. 2022 Dec 1;276(6):975-980. doi: 10.1097/SLA.0000000000005377. Epub 2022 Jan 25.

Reference Type: DERIVED

PMID: 35081564 (View on PubMed)

Other Identifiers

STU00204024

Identifier Type: -

Identifier Source: org_study_id