PDL and Fractional Photothermolysis for Postsurgical Scars

NCT03057964 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STU00204024
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PDL (Pulsed Dye Laser) and Fractional Photothermolysis

EXPERIMENTAL

Device: PDL (Pulsed Dye Laser); Device: Fractional Photothermolysis Laser

Control

NO INTERVENTION

Interventions

PDL (Pulsed Dye Laser) DEVICE

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

Also known as: Pulsed Dye Laser

PDL (Pulsed Dye Laser) and Fractional Photothermolysis

Fractional Photothermolysis Laser DEVICE

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

Also known as: Fraxel Laser

PDL (Pulsed Dye Laser) and Fractional Photothermolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years old
• Fitzpatrick skin types I-VI
• Subjects are in good health as judged by the investigator.
• 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.
• Subjects applying topical retinoids, must discontinue one week prior to treatment.
• 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.

You may not qualify if:

• History of recurrent facial or labial herpes simplex infection
• Subjects applying topical retinoids, must discontinue one week prior to treatment.
• Subjects with a history of hypertrophic scars or keloids
• Pregnant or breast feeding
• Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
• Subjects who are unable to understand the protocol or give informed consent.
• Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 35081564 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 20, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)