Title

Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    hydroquinone triamcinolone tretinoin ...
  • Study Participants

    29
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.
Study Started
Mar 31
2009
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Mar 11
2010
Estimate

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

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

Drug Modified Kligman's formula (Triple topical therapy)

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

  • Other names: modified Kligman formula

Non-ablative fractional laser Experimental

In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

Triple topical therapy Active Comparator

In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy.

Criteria

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).
No Results Posted