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Fractional Photothermolysis for Treating Melasma

NCT ID: NCT01245881

Last Updated: 2010-11-23

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

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF \>50).

Detailed Description

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Conditions

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Melasma

Keywords

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controlled trial fractional photothermolysis laser surgery melasma pigment disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment group

Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment

Group Type EXPERIMENTAL

Non-ablative fractional photothermolysis laser

Intervention Type DEVICE

* Wavelength: 1,550 nm;
* Energy: 15 mJ/MTZ;
* Total coverage: 20%;
* Total density: 1,048 MTZs/cm2;
* Density per pass: 131 MTZ/cm2;
* Number of passes: 8.

Control group

Group Type ACTIVE_COMPARATOR

broad-spectrum sunblock (SPF 50+)

Intervention Type OTHER

Interventions

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Non-ablative fractional photothermolysis laser

* Wavelength: 1,550 nm;
* Energy: 15 mJ/MTZ;
* Total coverage: 20%;
* Total density: 1,048 MTZs/cm2;
* Density per pass: 131 MTZ/cm2;
* Number of passes: 8.

Intervention Type DEVICE

broad-spectrum sunblock (SPF 50+)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (female/male) with clinical evidence of melasma;
* Fitzpatrick skin phototype I-III;
* Ability and willingness to comply with the requirements of the protocol.

Exclusion Criteria

* Pregnancy or nursing;
* Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
* Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
* Use of topical retinoids within 3 months prior to study enrolment;
* Use of topical hydroquinone within 6 months prior to study enrolment;
* Use of topical corticosteroids within 1 month prior to study enrolment;
* Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment;
* Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment;
* Coagulation disorders or anticoagulant treatment;
* Photo-sensitizing medication (e.g., tetracyclines, gold).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laser and Skin Centre Potsdam, Potsdam, Germany

UNKNOWN

Sponsor Role collaborator

Laserklinik Karlsruhe

OTHER

Sponsor Role lead

Responsible Party

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Laserklinik Karlsruhe, Karlsruhe, Germany

Locations

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Laserklinik Karlsruhe

Karlsruhe, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LK-13-2010

Identifier Type: -

Identifier Source: org_study_id