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

Sponsor:	Netherlands Institute for Pigment Disorders
Information provided by:	Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier:	NCT01085279

Purpose

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.

Condition	Intervention	Phase
Pigmentation Disorder	Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) Drug: Modified Kligman's formula (Triple topical therapy)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study

Resource links provided by NLM:

MedlinePlus related topics: Skin Pigmentation Disorders

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Netherlands Institute for Pigment Disorders:

Primary Outcome Measures:

Physician's global assessment [ Time Frame: T0, 3 weeks, and 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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 Outcome Measures:

L-value [ Time Frame: T0, 3 weeks and 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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 [ Time Frame: T0, 3 weeks and 3, and 6 months follow-up ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 weeks, 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 weeks, 3 and 6 months follow-up ] [ Designated as safety issue: Yes ]
Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.

Enrollment:	29
Study Start Date:	March 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: modified Kligman formula

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085279

Locations

Netherlands
Netherlands Institute for Pigment disorders
Amsterdam, Netherlands, 1105 AZ

Sponsors and Collaborators

Netherlands Institute for Pigment Disorders

Investigators

Principal Investigator:

Albert Wolkerstorfer, MD PhD

Netherlands Institute for Pigment Disorders

More Information

No publications provided

Responsible Party:	Albert Wolkerstorfer, MD PhD, Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier:	NCT01085279 History of Changes
Other Study ID Numbers:	fractional-3
Study First Received:	March 10, 2010
Last Updated:	March 10, 2010
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Netherlands Institute for Pigment Disorders:

fractional laser
melasma
topical bleaching

Additional relevant MeSH terms:

Pigmentation Disorders
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012