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1540nm Non Ablative Fractional Laser Treatment of Scars

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ClinicalTrials.gov Identifier: NCT01056211
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
  • 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 ]
  • Evaluation of the treatment related pain [ Time Frame: at 1 and 3 months ]
  • Evaluation of the adverse effect of 1540nm fractional laser versus untreated control site [ Time Frame: at 1 and 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
  • Evaluation of skin redness and pigmentation [ Time Frame: 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 [ Time Frame: at 1 and 3 months after treatment ]
  • Physician assessment for the treated and control region (PhGA) [ Time Frame: at 1 and 3 months after treatment ]
  • patient assessment for the treated and control region [ Time Frame: at 1 and 3 months after treatment ]
  • Photografic documentation of scar improvement [ Time Frame: at 1 and 3 months after treatment ]
  • Evaluation of histological difference in treated an non treated parts of the scar [ Time Frame: at 3 months after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 1540nm Non Ablative Fractional Laser Treatment of Scars
Official Title  ICMJE 1540nm Non Ablative Fractional Laser Treatment of Scars : a Prospective Single Blinded Within Patient Controlled Randomized Trial.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Scars
Intervention  ICMJE
  • Procedure: laser treatment
    Starlux 300 Lux 1540nm Fractional laser hand piece
  • Procedure: treatment without laser
    Starlux 300 Lux 1540nm Fractional laser hand piece
Study Arms  ICMJE
  • Active Comparator: hypopigmented scars treated with laser
    patients with hypopigmented scars treated with Starlux 300 Lux 1540nm Fractional laser hand piece
    Intervention: Procedure: laser treatment
  • Placebo Comparator: hypopigmented scars treated without laser
    patients with hypopigmented scars treated without laser
    Intervention: Procedure: treatment without laser
  • Active Comparator: hypertrophic scars treated with laser
    Intervention: Procedure: laser treatment
  • Placebo Comparator: hypertrophic scars not treated with laser
    Intervention: Procedure: treatment without laser
  • Active Comparator: scars due to grafts and reconstructions treated with laser
    scars due to grafts and reconstructions in the head and neck region
    Interventions:
    • Procedure: laser treatment
    • Procedure: laser treatment
  • Placebo Comparator: grafts and reconstructions scars not treated with laser
    scars due to grafts and reconstructions in the head and neck region
    Intervention: Procedure: treatment without laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01056211
Other Study ID Numbers  ICMJE 2009/626
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evelien Verhaeghe, MD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP