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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) | Device | 1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Wolkerstorfer, MD PhD | Netherlands Institute for Pigment Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Institute for Pigment disorders | Amsterdam | 1105 AZ | Netherlands |
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| Modified Kligman's formula (Triple topical therapy) | Drug | Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks |
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| 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 |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017495 | Hyperpigmentation |
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