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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Netherlands Institute for Pigment Disorders

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Netherlands Institute for Pigment Disorders

Dates:
Date Received: March 10, 2010
Date Started: March 2009
Date Completion:
Last Updated: March 10, 2010
Last Verified: March 2010