Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
NCT ID: NCT01085279
Last Updated: 2010-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2009-03-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
Modified Kligman's formula (Triple topical therapy)
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
Interventions
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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
Modified Kligman's formula (Triple topical therapy)
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Netherlands Institute for Pigment Disorders
OTHER
Responsible Party
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Netherlands Institute for Pigment Disorders
Principal Investigators
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Albert Wolkerstorfer, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Netherlands Institute for Pigment Disorders
Locations
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Netherlands Institute for Pigment disorders
Amsterdam, , Netherlands
Countries
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Other Identifiers
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fractional-3
Identifier Type: -
Identifier Source: org_study_id
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