search
Back to results

Fractional Laser as Treatment Option for Various Pigment Disorders (fractional-2)

Primary Purpose

Pigmentation Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ablative fractional laser therapy
Sponsored by
Netherlands Institute for Pigment Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigmentation Disorder focused on measuring Becker's nevus, ablative fractional laser therapy, randomized controlled trial, split-lesion design

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Becker nevus
  • Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
  • Age at least 18 years
  • Subject is willing and able to give written informed consent

Exclusion Criteria:

  • use of bleaching creams during the past six weeks
  • history of keloid
  • active eczema
  • suspected hypersensitivity to lidocaine or triple therapy
  • use of isotretinoin in the past six months
  • high exposure of the lesion to sunlight or UV light (UVA or UVB).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ablative fractional laser

    Control

    Arm Description

    In each patient, a square test region of 5-10 cm2 was treated with ablative fractional laser in three sessions in combination with intermittent topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream) to prevent laser-induced postinflammatory hyperpigmentation. Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.

    In each patient, a square test region of 5-10 cm2 was treated with topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream)alone (to allow comparison of the regions). Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.

    Outcomes

    Primary Outcome Measures

    Physician's global assessment
    Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).

    Secondary Outcome Measures

    L-value
    Improvement of hyperpigmentation was assessed by color measurement through reflectance spectroscopy (Microflash 200 d, Datacolor International, Lawrenceville, GA). This instrument, with an aperture of 4 mm, determines color by measuring the intensity of reflected light of particular wavelengths. In this study, the obtained L value, reflecting the lightness of the measured area of skin, was used.
    Melanin index
    Melanin index was measured using a spectrometer (Derma-Spectrometer, Cortex Technology ApS, Hadsund, Denmark) in order to assess changes in the amount of dermal and epidermal melanin.
    Patient's global assessment
    Patients were asked to score the improvement of hyperpigmentation on a visual analogue scale (VAS) from 0 to 10 (Patient's Global Assessment, PGA) at all follow-up moments.
    Patient's satisfaction
    Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
    Histopathologic assessment
    In order to evaluate for microscopic and ultrastructural treatment induced changes, 2 mm punch biopsies were taken from all patients at three months follow-up. Biopsies were taken from the optical centre of both treated and control site. All biopsy specimens were split for processing for light microscopy. .... was assessed by an independent blinded pathologist.

    Full Information

    First Posted
    March 8, 2010
    Last Updated
    March 8, 2010
    Sponsor
    Netherlands Institute for Pigment Disorders
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01083498
    Brief Title
    Fractional Laser as Treatment Option for Various Pigment Disorders
    Acronym
    fractional-2
    Official Title
    Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Netherlands Institute for Pigment Disorders

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.
    Detailed Description
    Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pigmentation Disorder
    Keywords
    Becker's nevus, ablative fractional laser therapy, randomized controlled trial, split-lesion design

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ablative fractional laser
    Arm Type
    Experimental
    Arm Description
    In each patient, a square test region of 5-10 cm2 was treated with ablative fractional laser in three sessions in combination with intermittent topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream) to prevent laser-induced postinflammatory hyperpigmentation. Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    In each patient, a square test region of 5-10 cm2 was treated with topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream)alone (to allow comparison of the regions). Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Ablative fractional laser therapy
    Other Intervention Name(s)
    Fraxel re:pair, Solta Medical Inc., Hayward, CA
    Intervention Description
    10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3
    Primary Outcome Measure Information:
    Title
    Physician's global assessment
    Description
    Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).
    Time Frame
    T0, 3 and 6 months follow-up
    Secondary Outcome Measure Information:
    Title
    L-value
    Description
    Improvement of hyperpigmentation was assessed by color measurement through reflectance spectroscopy (Microflash 200 d, Datacolor International, Lawrenceville, GA). This instrument, with an aperture of 4 mm, determines color by measuring the intensity of reflected light of particular wavelengths. In this study, the obtained L value, reflecting the lightness of the measured area of skin, was used.
    Time Frame
    T0, 3 and six months follow-up
    Title
    Melanin index
    Description
    Melanin index was measured using a spectrometer (Derma-Spectrometer, Cortex Technology ApS, Hadsund, Denmark) in order to assess changes in the amount of dermal and epidermal melanin.
    Time Frame
    T0, 3 and 6 months follow-up
    Title
    Patient's global assessment
    Description
    Patients were asked to score the improvement of hyperpigmentation on a visual analogue scale (VAS) from 0 to 10 (Patient's Global Assessment, PGA) at all follow-up moments.
    Time Frame
    3 and 6 months follow-up
    Title
    Patient's satisfaction
    Description
    Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
    Time Frame
    3 and 6 months follow-up
    Title
    Histopathologic assessment
    Description
    In order to evaluate for microscopic and ultrastructural treatment induced changes, 2 mm punch biopsies were taken from all patients at three months follow-up. Biopsies were taken from the optical centre of both treated and control site. All biopsy specimens were split for processing for light microscopy. .... was assessed by an independent blinded pathologist.
    Time Frame
    3 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Becker nevus Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders Age at least 18 years Subject is willing and able to give written informed consent Exclusion Criteria: use of bleaching creams during the past six weeks history of keloid active eczema suspected hypersensitivity to lidocaine or triple therapy use of isotretinoin in the past six months high exposure of the lesion to sunlight or UV light (UVA or UVB).

    12. IPD Sharing Statement

    Learn more about this trial

    Fractional Laser as Treatment Option for Various Pigment Disorders

    We'll reach out to this number within 24 hrs