1540nm Non Ablative Fractional Laser Treatment of Scars

Phase 4

Completed

• Conditions: Scars

• Registration Number: NCT01056211
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Scars are a frequent reason of consultation in a dermatological clinic. Their cosmetic aspect can play a key role in patient satisfaction and self-image.

Non ablative fractional infra-red laser treatment is a new concept in the laser field using arrays of microscopic thermal damage patterns to stimulate a wound healing response. There are different reports on the positive effect of these type of laser treatment in the treatment of acne scarring, striae, rythides, hypopigmented and hypertrophic scars.

The low morbidity of the treatment and the lack of satisfying treatment regimes for different types of scars makes it attractive to investigate the efficacy and safety of 4 treatment with the 1540nm non ablative fractional laser in the treatment of scars.

Objectives:

* To evaluate the efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional laser handpiece ( Palomar Medical Technologies ) 1 and 3 month after the last laser treatment for 3 different "scar" patient groups :

1. Patients with hypopigmented scars

2. Patients with hypertrophic scars

3. Patients with scars due to grafts and reconstructions in the head and neck region.

* To evaluate the treatment related pain. on a categorical scale from 0-10

* To evaluate the adverse effect of 1540nm fractional laser versus untreated control in the 3 patient groups.

The study design is a prospective single blinded randomised within-patient controlled study The study involves 6 visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site	at 1 and 3 months
efficacy of 4 laser treatments with Starlux 300 Lux 1540nm Fractional handpiece (Palomar Medical Technologies) 1 and 3 months after the last laser treatment in 3 different "scar" patient groups	at 1 and 3 months
Evaluation of the treatment related pain	at 1 and 3 months

Secondary Outcome Measures

Name	Time	Method
Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment	at 1 and 3 months after treatment
Physician assessment for the treated and control region (PhGA)	at 1 and 3 months after treatment
patient assessment for the treated and control region	at 1 and 3 months after treatment
Evaluation of skin redness and pigmentation	at 1 and 3 months after treatment
Evaluation of histological difference in treated an non treated parts of the scar	at 3 months after treatment
Photografic documentation of scar improvement	at 1 and 3 months after treatment

Trial Locations

Locations (1)

Univerisity Hospital Ghent; 🇧🇪 Ghent, Belgium