Prevention of Melasma Relapse During Summertime
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02061839|
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Melasma||Other: Sunscream with visible light protection Other: Sunscream||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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