Clinical trial NCT03057964: PDL and Fractional Photothermolysis for Postsurgical Scars
Official title: The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scar
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in score of Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Baseline and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.