1540nm Non Ablative Fractional Laser Treatment of Scars

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01056211
First received: January 25, 2010
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Scars
Procedure: laser treatment
Procedure: treatment without laser
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 [ Time Frame: at 1 and 3 months ] [ Designated as safety issue: No ]
  • Evaluation of the treatment related pain [ Time Frame: at 1 and 3 months ] [ Designated as safety issue: Yes ]
  • Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site [ Time Frame: at 1 and 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of skin redness and pigmentation [ Time Frame: at 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Compare different clinical scar assessment tools that can be used in the evaluation of clinical efficacy of the laser treatment [ Time Frame: at 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Physician assessment for the treated and control region (PhGA) [ Time Frame: at 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • patient assessment for the treated and control region [ Time Frame: at 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Photografic documentation of scar improvement [ Time Frame: at 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Evaluation of histological difference in treated an non treated parts of the scar [ Time Frame: at 3 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056211

Locations
Belgium
Univerisity Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Evelien Verhaeghe, MD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01056211     History of Changes
Other Study ID Numbers: 2009/626
Study First Received: January 25, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014