PDL and Fractional Photothermolysis for Postsurgical Scars

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Other names: Pulsed Dye Laser

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.

Other names: Fraxel Laser

Primary outcomes

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".

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2027
Study completion: 2027
First posted: Feb 20, 2017
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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