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

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Procedure: Laser treatment

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser treated HSc scar; Co2 laser treatment	Procedure: Laser treatment; CORE fractional CO2 laser treatment
NO_INTERVENTION: Control scar; Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Characteristics changes	Erythema, elasticity and thickness measures	baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction Questionnaire	Questionnaire	baseline, 24 weeks

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (ACTUAL): August 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Cicatrix; Burns; Cicatrix, Hypertrophic
• Other Study ID Numbers: CE14-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES