1540nm Non Ablative Fractional Laser Treatment of Scars

1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.

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.

Study Overview

• Status: Completed
• Conditions: Scars
• Intervention / Treatment: Procedure: laser treatment; Procedure: treatment without laser

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Univerisity Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The patients needs to have a scar fulfilling the inclusion and exclusion criteria of one of the 3 patient groups:

Patient group 1: patients with hypopigmented scars :

Inclusion criteria:

• Patients with a hypopigmented scar allowing 2 side by side test areas of similar sizes and appearance within the same anatomical region.
• Skin type 1-4
• Age at least 18 years old
• Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

• Pregnancy and lactation
• Oral retinoid drugs within the past 6 months

Patientgroup 2: patients with hypertrophic scars :

Inclusion criteria:

• Patients with a hypertrophic scar allowing 2 side by site test areas of similar sizes and appearance within the same anatomical region.
• Skin type 1-4
• Male / Female
• Age at least 18 years old
• Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

• Pregnancy and lactation
• Oral retinoid drugs within the past 6 months

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

Inclusion criteria:

• Patients with a graft or reconstruction with 2 site by site test areas of similar sizes and appearance within the same anatomical region (head and neck region).
• Skin type 1-4
• Age at least 18 years old
• Willingness and ability to give written informed consent and to comply with the requirements of the protocol

Exclusion criteria:

• Pregnancy and lactation
• Oral retinoid drugs within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hypopigmented scars treated with laser; patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece	Procedure: laser treatment; Starlux 300 Lux 1540nm Fractional laser hand piece
Placebo Comparator: hypopigmented scars treated without laser; patients with hypopigmented scars treated without laser	Procedure: treatment without laser; Starlux 300 Lux 1540nm Fractional laser hand piece
Active Comparator: hypertrophic scars treated with laser	Procedure: laser treatment; Starlux 300 Lux 1540nm Fractional laser hand piece
Placebo Comparator: hypertrophic scars not treated with laser	Procedure: treatment without laser; Starlux 300 Lux 1540nm Fractional laser hand piece
Active Comparator: scars due to grafts and reconstructions treated with laser; scars due to grafts and reconstructions in the head and neck region	Procedure: laser treatment; Starlux 300 Lux 1540nm Fractional laser hand piece
Placebo Comparator: grafts and reconstructions scars not treated with laser; scars due to grafts and reconstructions in the head and neck region	Procedure: treatment without laser; Starlux 300 Lux 1540nm Fractional laser hand piece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site	at 1 and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of skin redness and pigmentation	at 1 and 3 months after treatment
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
Photografic documentation of scar improvement	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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Evelien Verhaeghe, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 25, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2009/626