CO2 Laser Phototherapy for Management of Mature Burn Scars

NCT03197649 | Completed

• 1 other identifier: 950482
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Conditions

Burn Scar

Outcome Measures

Primary Outcomes (1)

• Change in scar assessment evaluation

  Patient and Observer Scar Assessment Scale

  Prior to initial treatment and no sooner than 3 months following last treatment

Study Arms (2)

Control

NO INTERVENTION

No laser phototherapy treatment

Laser phototherapy treatment

EXPERIMENTAL

Laser phototherapy treatment administered in OR

Procedure: Laser phototherapy treatment

Interventions

Laser phototherapy treatment PROCEDURE

Laser phototherapy treatment administered in OR

Laser phototherapy treatment

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 3 to 21
• Patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone CO2 laser therapy for scar revision.
• Scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study
• Entry into this study is open to pediatric patients of both genders.
• Entry into this study is open to pediatric patients of all ethnic backgrounds.
• Entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test

You may not qualify if:

• Patients with scars less than 2 years old
• Patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active Zoster infection)
• Patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.

Sponsors & Collaborators

• University of California, Davis: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Hospitals for Children

Sacramento, California, 95817, United States

Location

Study Officials

• Pirko Maguina, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 23, 2017
• Study Start: May 22, 2017
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)