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

This study has been completed.
Sponsor:
Information provided by:
Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier:
NCT01085279
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Pigmentation Disorders
Pathologic Processes
Skin Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014