Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/31/2018 |
| Start Date: | November 2016 |
| End Date: | December 2019 |
| Contact: | Kavita Darji, MD |
| Email: | kavita.darji@health.slu.edu |
| Phone: | 314-256-3407 |
A Single Center, Double-blinded Randomized Placebo-controlled Trial to Evaluate Surgical Scars After Treatment With Fractional Carbon Dioxide Rejuvenation Laser Therapy
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.
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.
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.
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.
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
We found this trial at
1
site
1755 South Grand Boulevard
Saint Louis, Missouri 63122
Saint Louis, Missouri 63122
Phone: 314-256-3407
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