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

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

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 Overview

• Status: Completed
• Conditions: Pigmentation Disorder
• Intervention / Treatment: Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser); Drug: Modified Kligman's formula (Triple topical therapy)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Netherlands Institute for Pigment Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Fraxel 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; Other Names: Fraxel re:store, Solta Medical Inc., Hayward, CA
Active Comparator: 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.	Drug: Modified Kligman's formula (Triple topical therapy); Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks; Other Names: modified Kligman formula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Netherlands Institute for Pigment Disorders
• Investigators: Principal Investigator: Albert Wolkerstorfer, MD PhD, Netherlands Institute for Pigment Disorders

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 11, 2010
• Last Update Submitted That Met QC Criteria: March 10, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: melasma; fractional laser; topical bleaching
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: fractional-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No