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NCT Number: NCT03240718

Pilot Study of the Ablative Fractional CO2 Laser in 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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser treatment

Procedure

CORE fractional CO2 laser treatment

Primary outcomes

  1. Skin Characteristics changes

    Time frame: baseline, 12 weeks and 24 weeks

    Erythema, elasticity and thickness measures

Secondary outcomes

  1. Satisfaction Questionnaire

    Time frame: baseline, 24 weeks

    Questionnaire

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2017
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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