Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
- Conditions
- Pigmentation Disorder
- Interventions
- Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)Drug: Modified Kligman's formula (Triple topical therapy)
- Registration Number
- NCT01085279
- Lead Sponsor
- Netherlands Institute for Pigment Disorders
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-ablative fractional laser Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) 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 Modified Kligman's formula (Triple topical therapy) 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.
- Primary Outcome Measures
Name Time Method Physician's global assessment 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 Outcome Measures
Name Time Method L-value 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 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 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 3 weeks, 3 and 6 months follow-up Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
Trial Locations
- Locations (1)
Netherlands Institute for Pigment disorders
🇳🇱Amsterdam, Netherlands