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Completed

NCT Number: NCT01083498

Fractional Laser as Treatment Option for Various Pigment Disorders

The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.

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Key information

Conditions

Pigmentation Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Ablative fractional laser therapy

Device

10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3

Other names: Fraxel re:pair, Solta Medical Inc., Hayward, CA

Primary outcomes

  1. Physician's global assessment

    Time frame: T0, 3 and 6 months follow-up

    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 outcomes

  1. L-value

    Time frame: T0, 3 and six months follow-up

    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.

  2. Melanin index

    Time frame: T0, 3 and 6 months follow-up

    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.

  3. Patient's global assessment

    Time frame: 3 and 6 months follow-up

    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.

  4. Patient's satisfaction

    Time frame: 3 and 6 months follow-up

    Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.

  5. Histopathologic assessment

    Time frame: 3 months follow-up

    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.

Sponsors and collaborators

Lead sponsor

Netherlands Institute for Pigment Disorders

Other

Registry information

Official study title

Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study

Acronym: fractional-2

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 9, 2010
Registry last updated
Mar 9, 2010

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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