Prevention of Melasma Relapse During Summertime

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Melasma

Exclusion criteria

Other pigmentary disorders associated (including PIH)

Treatment and study plan

Sunscream with visible light protection

Other

Sunscream

Other

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre de Pharmacologie Clinique Applique a la Dermatologie

Other

Collaborators

BIODERMA

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Feb 13, 2014
Registry last updated: Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed