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1540nm Non Ablative Fractional Laser Treatment of Scars

NCT01056211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-12-05

No results posted yet for this study

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.

Conditions

  • Scars

Interventions

PROCEDURE

laser treatment

Starlux 300 Lux 1540nm Fractional laser hand piece

PROCEDURE

treatment without laser

Starlux 300 Lux 1540nm Fractional laser hand piece

PROCEDURE

laser treatment

Starlux 300 Lux 1540nm Fractional laser hand piece

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Evelien Verhaeghe, MD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056211 on ClinicalTrials.gov