Melasma
Conditions
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.
Interventions
OTHERSunscream with visible light protection
OTHERSunscream
Sponsors
BIODERMA
Centre de Pharmacologie Clinique Applique a la Dermatologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Melasma
Exclusion criteria
* Other pigmentary disorders associated (including PIH)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed