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Completed

NCT Number: NCT01085279

Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)

The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.

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Key information

Conditions

Pigmentation Disorder Hyperpigmentation Melanosis 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

Primary location

Netherlands Institute for Pigment disorders

Amsterdam, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Melasma
  • 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

Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)

Device

1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5

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

Modified Kligman's formula (Triple topical therapy)

Drug

Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks

Other names: modified Kligman formula

Primary outcomes

  1. Physician's global assessment

    Time frame: T0, 3 weeks, and 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 weeks and 3 and 6 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, indicating the lightness of the measured area of skin, was used.

  2. Melanin index

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

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

Sponsors and collaborators

Lead sponsor

Netherlands Institute for Pigment Disorders

Other

Registry information

Official study title

Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 11, 2010
Registry last updated
Mar 11, 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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