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

NCT ID: NCT01085279

Last Updated: 2010-03-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pigmentation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Group Type EXPERIMENTAL

Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Modified Kligman's formula (Triple topical therapy)

Intervention Type DRUG

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

Intervention Type DEVICE

Modified Kligman's formula (Triple topical therapy)

Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks

Intervention Type DRUG

Other Intervention Names

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Fraxel re:store, Solta Medical Inc., Hayward, CA modified Kligman formula

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Netherlands Institute for Pigment Disorders

OTHER

Sponsor Role lead

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

Site Status

Countries

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Netherlands

Other Identifiers

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fractional-3

Identifier Type: -

Identifier Source: org_study_id

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