NCT03240718

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
Last Updated

August 17, 2017

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

February 3, 2017

Last Update Submit

August 15, 2017

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • Skin Characteristics changes

    Erythema, elasticity and thickness measures

    baseline, 12 weeks and 24 weeks

Secondary Outcomes (1)

  • Satisfaction Questionnaire

    baseline, 24 weeks

Study Arms (2)

Laser treated HSc scar

EXPERIMENTAL

Co2 laser treatment

Procedure: Laser treatment

Control scar

NO INTERVENTION

Standard care

Interventions

Laser treatmentPROCEDURE

CORE fractional CO2 laser treatment

Laser treated HSc scar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Bernadette Nedelec, PhD

    CRCHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2017

First Posted

August 7, 2017

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

August 17, 2017

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share