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Prevention of Melasma Relapse During Summertime

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sunscream with visible light protection
Sunscream
Sponsored by
Centre de Pharmacologie Clinique Applique a la Dermatologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Melasma

Exclusion Criteria:

  • Other pigmentary disorders associated (including PIH)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Teinted sunscream

    Regular sunscream

    Arm Description

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

    UVA and UVB protection

    Outcomes

    Primary Outcome Measures

    Comparison between MASI scores before prevention treatment and after 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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2014
    Last Updated
    February 12, 2014
    Sponsor
    Centre de Pharmacologie Clinique Applique a la Dermatologie
    Collaborators
    BIODERMA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02061839
    Brief Title
    Prevention of Melasma Relapse During Summertime
    Official Title
    Prevention of Melasma Relapse During Summertime
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre de Pharmacologie Clinique Applique a la Dermatologie
    Collaborators
    BIODERMA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Teinted sunscream
    Arm Type
    Experimental
    Arm Description
    UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator)
    Arm Title
    Regular sunscream
    Arm Type
    Active Comparator
    Arm Description
    UVA and UVB protection
    Intervention Type
    Other
    Intervention Name(s)
    Sunscream with visible light protection
    Intervention Type
    Other
    Intervention Name(s)
    Sunscream
    Primary Outcome Measure Information:
    Title
    Comparison between MASI scores before prevention treatment and after 6 months
    Description
    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
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Melasma Exclusion Criteria: Other pigmentary disorders associated (including PIH)

    12. IPD Sharing Statement

    Learn more about this trial

    Prevention of Melasma Relapse During Summertime

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