Prevention of Melasma Relapse During Summertime

NCT ID: NCT02061839

Last Updated: 2014-02-13

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.

Detailed Description

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40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen).

There will be 3 visits: Baseline, T2.5months and T5months (final visit).

Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure.

Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.

Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Teinted sunscream

UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator)

Group Type EXPERIMENTAL

Sunscream with visible light protection

Intervention Type OTHER

Regular sunscream

UVA and UVB protection

Group Type ACTIVE_COMPARATOR

Sunscream

Intervention Type OTHER

Interventions

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Sunscream with visible light protection

Intervention Type OTHER

Sunscream

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Melasma

Exclusion Criteria

* Other pigmentary disorders associated (including PIH)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BIODERMA

UNKNOWN

Sponsor Role collaborator

Centre de Pharmacologie Clinique Applique a la Dermatologie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2013-A00073-42

Identifier Type: -

Identifier Source: org_study_id

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