Fractional Photothermolysis for the Treatment of Burn Scars

NCT01005992 | Unknown Phase 1

• 1 other identifier: CLCCQFQ-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.

Conditions

Scar

Keywords

Scars secondary to injuries to tissues caused by contact with physical (heat, electricity) o chemical agent.

Outcome Measures

Primary Outcomes (2)

• Evidence of improvement in color and texture of burn scars, using digital colorimeter and digital photography.

  5 months

• Adverse effects: pain, erythema, edema, hypopigmentation, hyperpigmentation, hypertrophic scar and keloid formation

  5 months

Secondary Outcomes (3)

• Change in surface area and perimeter of burn scar

  5 months

• Tissue pliability, elevation and flexibility with a digital piedemeter

  5 months

• Change in collagen fiber organization and blood vessel density with a reflectance laser confocal microscope.

  5 months

Study Arms (2)

Laser treated scar

EXPERIMENTAL

The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.

Procedure: Fractional laser treatment

Standard scar management

ACTIVE COMPARATOR

The standard scar management arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.

Procedure: Standard scar management

Interventions

Fractional laser treatment PROCEDURE

A complete treatment will consist in four laser sessions with a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc at 1-month intervals. Treatment will be delivered with a 15-mm tip and concomitant air-cooling system (Zimmer MedizinSystems, Irvine, CA). Fluence and treatment level will be registered on every session and will be adjusted according to patient tolerance.

Laser treated scar

Standard scar management PROCEDURE

The standard treated scar arm consists of a similar lesion in an equivalent location in the same patient or the half of a lesion that is suitable to be divided (size at least 4% body surface area). This arm will be managed only with standard burn treatment modalities.

Standard scar management

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
• The scar should be slightly elevated, with erythema and with no signs of keloid formation.
• Maximum scar dimension: 0.2 - 1% body surface area.
• Acceptance of informed consent for laser treatment.

You may not qualify if:

• Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
• Previous surgical treatment (i.e. graft)

Sponsors & Collaborators

• Clinica las Condes, Chile: lead
• Corporacion de ayuda al niño quemado (COANIQUEM): collaborator
• Solta Medical: collaborator

Study Sites (1)

Clinica Las Condes

Santiago, RM, Chile

Location

Related Publications (6)

• Chrastil B, Glaich AS, Goldberg LH, Friedman PM. Second-generation 1,550-nm fractional photothermolysis for the treatment of acne scars. Dermatol Surg. 2008 Oct;34(10):1327-32. doi: 10.1111/j.1524-4725.2008.34284.x.

  PMID: 19040687 BACKGROUND

• Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.

  PMID: 17338685 BACKGROUND

• Haedersdal M. Fractional ablative CO(2) laser resurfacing improves a thermal burn scar. J Eur Acad Dermatol Venereol. 2009 Nov;23(11):1340-1. doi: 10.1111/j.1468-3083.2009.03215.x. Epub 2009 Mar 4. No abstract available.

  PMID: 19309424 BACKGROUND

• Haedersdal M, Moreau KE, Beyer DM, Nymann P, Alsbjorn B. Fractional nonablative 1540 nm laser resurfacing for thermal burn scars: a randomized controlled trial. Lasers Surg Med. 2009 Mar;41(3):189-95. doi: 10.1002/lsm.20756.

  PMID: 19291747 BACKGROUND

• Waibel J, Beer K. Fractional laser resurfacing for thermal burns. J Drugs Dermatol. 2008 Jan;7(1):59-61.

  PMID: 18246699 BACKGROUND

• Waibel J, Beer K. Ablative fractional laser resurfacing for the treatment of a third-degree burn. J Drugs Dermatol. 2009 Mar;8(3):294-7.

  PMID: 19271380 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo J Schwartz, MD

  Clinica Las Condes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Schwartz, MD

CONTACT

56-2-6108661; schwartz.rodrigo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: November 2, 2009

Record last verified: 2009-10

Locations

CL (1)