Back to resultsFractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
Primary Purpose
Pigmentation Disorder
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)
Modified Kligman's formula (Triple topical therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Pigmentation Disorder focused on measuring fractional laser, melasma, topical bleaching
Eligibility 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).
Sites / Locations
- Netherlands Institute for Pigment disorders
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-ablative fractional laser
Triple topical therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
Patient's satisfaction
Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
Full Information
NCT ID
NCT01085279
First Posted
March 10, 2010
Last Updated
March 10, 2010
Sponsor
Netherlands Institute for Pigment Disorders
1. Study Identification
Unique Protocol Identification Number
NCT01085279
Brief Title
Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Netherlands Institute for Pigment Disorders
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmentation Disorder
Keywords
fractional laser, melasma, topical bleaching
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-ablative fractional laser
Arm Type
Experimental
Arm Description
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.
Arm Title
Triple topical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)
Other Intervention Name(s)
Fraxel re:store, Solta Medical Inc., Hayward, CA
Intervention Description
1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5
Intervention Type
Drug
Intervention Name(s)
Modified Kligman's formula (Triple topical therapy)
Other Intervention Name(s)
modified Kligman formula
Intervention Description
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
Primary Outcome Measure Information:
Title
Physician's global assessment
Description
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 Outcome Measure Information:
Title
L-value
Description
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
Title
Melanin index
Description
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
Title
Patient's global assessment
Description
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
Title
Patient's satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Wolkerstorfer, MD PhD
Organizational Affiliation
Netherlands Institute for Pigment Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netherlands Institute for Pigment disorders
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
12. IPD Sharing Statement
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Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
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