Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

Not Applicable

Completed

• Conditions: Burns
• Interventions: Procedure: Laser treatment

• Registration Number: NCT03240718
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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 Timeline

• Study Start: 2015-02
• Status Verified: 2015-12
• Primary Completion: 2016-05
• Study Completion: 2016-12
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser treated HSc scar	Laser treatment	Co2 laser treatment

Primary Outcome Measures

Name	Time	Method
Skin Characteristics changes	baseline, 12 weeks and 24 weeks	Erythema, elasticity and thickness measures

Secondary Outcome Measures

Name	Time	Method
Satisfaction Questionnaire	baseline, 24 weeks	Questionnaire