Pigmentation Disorder
Conditions
Keywords
fractional laser, melasma, topical bleaching
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.
Interventions
DEVICEFraxel 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
DRUGModified Kligman's formula (Triple topical therapy)
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
Sponsors
Netherlands Institute for Pigment Disorders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed