Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Primary Endpoint
- Skin Characteristics changes
Study Overview
Brief Summary
This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.
Detailed Description
Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Fitzpatrick skin type <IV (37),
- •Have sustained a thermal burn injury,
- •Have at least 2 independent sites that show clinical evidence of HSc,
- •Are 2 months or more post-injury.
Exclusion Criteria
- •Subjects with skin phototypes IV or higher,
- •With history of keloidal scarring,
- •Who have coagulation disorder,
- •Are taking immunosuppressive medications,
- •If the mechanism of injury is an electrical, chemical, or cold injury,
- •Any underlying active skin disease,
- •Have taken oral Isotreinoin within the last 6 months,
- •Photosensitivity or have taken photosensitizing medications,
- •Pregnancy,
- •Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
Arms & Interventions
Laser treated HSc scar
Co2 laser treatment
Intervention: Laser treatment (Procedure)
Control scar
Standard care
Outcomes
Primary Outcomes
Skin Characteristics changes
Time Frame: baseline, 12 weeks and 24 weeks
Erythema, elasticity and thickness measures
Secondary Outcomes
- Satisfaction Questionnaire(baseline, 24 weeks)