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

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ClinicalTrials.gov Identifier: NCT02985151
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ramona Behshad, MD, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Cicatrix Carbon Dioxide Laser Device: Syneron-Candela CO2RE Laser Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Center, Double-blinded Randomized Placebo-controlled Trial to Evaluate Surgical Scars After Treatment With Fractional Carbon Dioxide Rejuvenation Laser Therapy
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: High Energy Treatment Group
Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group will be offered a third optional treatment at one of these settings.
Device: Syneron-Candela CO2RE Laser
This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.

Placebo Comparator: Low Energy Treatment Group
Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. Individuals in this group will be offered two optional high energy treatments subsequent to receiving the two light energy treatments.
Device: Syneron-Candela CO2RE Laser
This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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:

  • Surgical scar present in the head or neck region for at least 8 weeks.
  • Capable of providing informed consent
  • Available for study appointments
  • Follows directions of post-treatment instructions

Exclusion Criteria:

  • Individuals under the age of 18
  • Prior laser treatment to the head or neck
  • History of keloid formation
  • Isotretinoin use in the last 6 months prior to study enrollment
  • Allergy to topical lidocaine
  • Pregnant women

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): NCT02985151


Contacts
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Contact: Kavita Darji, MD 314-256-3407 kavita.darji@health.slu.edu
Contact: Rosemary King, PA-C 314-256-3436 kingrm@slu.edu

Locations
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United States, Missouri
Saint Louis University Department of Dermatology-Des Peres Med Arts Pavilion II Recruiting
Saint Louis, Missouri, United States, 63122
Contact: Kavita Darji, MD    314-256-3407    kavita.darji@health.slu.edu   
Contact: Rosemary King, PA-C    314-256-3436    kingrm@slu.edu   
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Ramona Behshad, MD Saint Louis University, Department of Dermatology

Publications:
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Responsible Party: Ramona Behshad, MD, Assistant Professor, Department of Dermatology, St. Louis University
ClinicalTrials.gov Identifier: NCT02985151     History of Changes
Other Study ID Numbers: SLU-27403
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data may be accessed after publication of the results in a medical journal.

Keywords provided by Ramona Behshad, MD, St. Louis University:
Scar
Carbon Dioxide Laser
Laser Ablation

Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes