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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240718
• Other study ID #: CE14-122
• Status: Completed
• Phase: N/A
• First received: February 3, 2017
• Last updated: August 15, 2017
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Cicatrix, Hypertrophic
• Hypertrophy

Intervention

Procedure:
• Laser treatment
CORE fractional CO2 laser treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Characteristics changes	Erythema, elasticity and thickness measures	baseline, 12 weeks and 24 weeks
Secondary	Satisfaction Questionnaire	Questionnaire	baseline, 24 weeks