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Prevention of Melasma Relapse During Summertime

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ClinicalTrials.gov Identifier: NCT02061839
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
BIODERMA
Information provided by (Responsible Party):
Centre de Pharmacologie Clinique Applique a la Dermatologie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melasma Other: Sunscream with visible light protection Other: Sunscream Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Melasma Relapse During Summertime
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013

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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Melasma

Exclusion Criteria:

  • Other pigmentary disorders associated (including PIH)

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Responsible Party: Centre de Pharmacologie Clinique Applique a la Dermatologie
ClinicalTrials.gov Identifier: NCT02061839     History of Changes
Other Study ID Numbers: 2013-A00073-42
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases