Prevention of Melasma Relapse During Summertime

February 12, 2014 updated by: Centre de Pharmacologie Clinique Applique a la Dermatologie
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Melasma

Exclusion Criteria:

  • Other pigmentary disorders associated (including PIH)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teinted sunscream
UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator)
Other: Sunscream with visible light protection
Active Comparator: Regular sunscream
UVA and UVB protection
Other: Sunscream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between MASI scores before prevention treatment and after 6 months
Time Frame: 6 months
MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Pharmacologie Clinique Applique a la Dermatologie

Collaborators

BIODERMA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00073-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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