Prevention of Melasma Relapse During Summertime
- Conditions
- Melasma
- Interventions
- Other: Sunscream with visible light protectionOther: Sunscream
- Registration Number
- NCT02061839
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Melasma
- Other pigmentary disorders associated (including PIH)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teinted sunscream Sunscream with visible light protection UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator) Regular sunscream Sunscream UVA and UVB protection
- Primary Outcome Measures
Name Time Method Comparison between MASI scores before prevention treatment and after 6 months 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
Name Time Method