Prevention of Melasma Relapse During Summertime

Centre de Pharmacologie Clinique Applique a la Dermatologie

Status: Completed

Conditions: Melasma

Treatments: Other: Sunscream with visible light protection; Other: Sunscream

Study type: Interventional

Funder types: Other

Identifiers

NCT02061839

2013-A00073-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Melasma

Exclusion criteria

• Other pigmentary disorders associated (including PIH)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Teinted sunscream

Experimental group

Description:

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

Treatment:

Other: Sunscream with visible light protection

Regular sunscream

Active Comparator group

Description:

UVA and UVB protection

Treatment:

Other: Sunscream