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PDL and Fractional Photothermolysis for Postsurgical Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057964
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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



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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057964


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University
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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    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes