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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pigmentation Disorder

Intervention / Treatment
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* Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)
* Drug: Modified Kligman's formula (Triple topical therapy)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-ablative fractional laser<br>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. | Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)<br>* 1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5<br>* Other names: Fraxel re:store, Solta Medical Inc., Hayward, CA;|
| Active Comparator: Triple topical therapy<br>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. | Drug: Modified Kligman's formula (Triple topical therapy)<br>* Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks<br>* Other names: modified Kligman formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's global assessment | 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). | T0, 3 weeks, and 3 and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L-value | 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. | T0, 3 weeks and 3 and 6 months follow-up | 
| Melanin index | 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. | T0, 3 weeks and 3, and 6 months follow-up | 
| Patient's global assessment | 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. | 3 weeks, 3 and 6 months follow-up | 
| Patient's satisfaction | Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10. | 3 weeks, 3 and 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional laser, melasma, topical bleaching