Clinical Trial: Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single Center, Double-blinded Randomized Placebo-controlled Trial to Evaluate Surgical Scars After Treatment With Fractional Carbon Dioxide Rejuvenation Laser Therapy

Brief Summary: This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has not had laser therapy may be eligible to participate. The visits occur every three months for up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a lower energy treatment during the study. Subjects and raters will be blinded to which therapy level the patient receives. At each visit, the scars will be photographed and the subject will complete a questionnaire to rate the scar prior to treatment. Three physicians will evaluate the scar at each visit. One rater will evaluate the scars in person during the visit, while the other two raters will evaluate the scars using photographs after each visit. During the first three study visits, subjects will receive their assigned treatment, obtain post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other skin changes after treatment. At the third study visit, subjects will have the option to receive additional treatments or terminate their participation in the study. The fourth visit for those who continue will be a treatment visit for one group and the fifth visit will be for data collection, with no treatment offered.

Detailed Summary:

In dermatology, the use of Light Amplification by Stimulated Emission of Radiation (laser) has revolutionized the management of various conditions including angiomas, vitiligo, wrinkles, and scars. (Omi, 2014 and Chapas, 2008) Scars result from sub-optimal collagen production during wound healing leading to topographical irregularities. To effectively modify these defects, any treatment must be capable of penetrating the epidermis and eliciting dermal remodeling at a depth of at least 1 mm. The 10,600 nm carbon dioxide (CO2) laser utilizes high energy at short durations to vaporize intra- and extra-cellular water, resulting in tissue ablation causing a substantial thermal injury to the dermis, reducing the likelihood of additional scarring. The CO2 laser can stimulate collagen production and theoretically improve scar thickness, pliability, and texture.

This study is a prospective, randomized double-blinded placebo-controlled trial to evaluate the efficacy of fractionated carbon dioxide laser in improving surgical scars on the head and neck over 3-5 study visits for a duration of 12.5 months. Scar assessments will be based on objective changes identified on pictures taken with the Canfield Vectra M3 3D Imaging System and subjective changes identified with the Patient and Observer Scar Assessment Scale (POSAS), a validated scar scale. As a secondary objective, the study will evaluate the tolerability of the laser, by assessing the severity and duration of known side effects of laser therapy such as erythema, edema, burning sensation, post-inflammatory pigment changes, infection, scarring, xerosis, pruritus, bronzing, and any other adverse events that arise following treatment. Subjects will be given a diary after each treatment to document this information.


Sponsor: St. Louis University

Current Primary Outcome:

  • Scar dimensions [ Time Frame: 12.5 months ]
    Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
  • Clinical features of scar from participant and objective observer perspectives [ Time Frame: 12.5 months ]
    Utilizing a scar assessment scale, the study will evaluate features of color change, thickness, width, texture of the scar, pain associated with the scar, and itching associated with the scar by the patient and blinded clinical evaluators.


Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerability Associated with the Laser Treatment [ Time Frame: 12.5 months ]

Participants will be given a diary to record the severity and duration of symptoms for thirty days after each laser treatment: redness, swelling, burning sensation, post-inflammatory pigment changes, infection, scarring, dry skin, itching, bronzing, and any other adverse events that arise following treatment


Original Secondary Outcome: Same as current

Information By: St. Louis University

Dates:
Date Received: December 5, 2016
Date Started: November 2016
Date Completion: April 2018
Last Updated: December 7, 2016
Last Verified: December 2016