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

Netherlands Institute for Pigment Disorders29 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pigmentation Disorder

Interventions

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

Modified Kligman's formula (Triple topical therapy)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Netherlands Institute for Pigment disorders

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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).

Time frame: T0, 3 weeks, and 3 and 6 months follow-up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 weeks, 3 and 6 months follow-up

Data from ClinicalTrials.gov

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