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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cicatrix Carbon Dioxide Laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a crossover study where subjects are randomized into two arms. Subjects in the sham arm are allowed to crossover at the end of their initial intervention period.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Syneron-Candela CO2RE Laser

Intervention Type DEVICE

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.

Low Energy Placebo 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. The Light mode is a low energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high energy treatments subsequent to receiving the two light energy treatments.

Group Type PLACEBO_COMPARATOR

Syneron-Candela CO2RE Laser

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes