Multicentric French parallel double-blind randomized versus placebo study
Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
tacrolimus 0.1% ointment applied twice a day for the experimental group during 24 weeks placebo ointment applied twice a day for the control group during 24 weeks
University Hospital of Bordeaux - St André Hospital
Bordeaux, France
Regional Hospital Center of Le Mans -
Le Mans, France
University Hospital Center of Nice - Hôpital de l'Archet
Nice, France
University Hospital Center of Rennes - Hôpital Pontchaillou
Rennes, France
Percentage of repigmented surface area of the target lesion ≥75%
To test the efficacy of a 24 weeks months Tacrolimus 0.1% ointment treatment vs placebo in an adult population with stable non-segmental vitiligo of the face. Therapeutic success is defined as the variation in percentage of repigmented surface area of the target lesion ≥75% at 24 weeks months.
Time frame: One year
Variation in percentage of repigmented surface area
Variation in percentage of repigmented surface area of the target lesion between week 24 and week 48 (observation period) in patients who were successfully treated (observation period)
Time frame: 24 weeks
Variation in percentage of repigmented surface area
Variation in percentage of repigmented surface area of the target lesion between week 24 and week 48 (observation period) in patients who were successfully treated (observation period)
Time frame: 48 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time frame: 12 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time frame: 24 weeks
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time frame: 48 weeks
Variation of the physician global evaluation of treatment efficacy
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Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit
Time frame: 12 weeks
Variation of the physician global evaluation of treatment efficacy
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Time frame: 24 weeks
Variation of the physician global evaluation of treatment efficacy
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Time frame: 48 weeks
Variation of the Dermatology Life Quality Index
Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups
Time frame: 24 weeks
Number of participants with Adverse events
Time frame: 24 weeks