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NCT Number: NCT01056211

1540nm Non Ablative Fractional Laser Treatment of Scars

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.

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Key information

Conditions

Scars Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univerisity Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser treatment

Procedure

Starlux 300 Lux 1540nm Fractional laser hand piece

treatment without laser

Procedure

Starlux 300 Lux 1540nm Fractional laser hand piece

Primary outcomes

  1. 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

  2. Evaluation of the treatment related pain

    Time frame: at 1 and 3 months

  3. Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site

    Time frame: at 1 and 3 months

Secondary outcomes

  1. Evaluation of skin redness and pigmentation

    Time frame: at 1 and 3 months after treatment

  2. 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

  3. Physician assessment for the treated and control region (PhGA)

    Time frame: at 1 and 3 months after treatment

  4. patient assessment for the treated and control region

    Time frame: at 1 and 3 months after treatment

  5. Photografic documentation of scar improvement

    Time frame: at 1 and 3 months after treatment

  6. Evaluation of histological difference in treated an non treated parts of the scar

    Time frame: at 3 months after treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2010
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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