Clinical trial NCT02466997: Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC
Official title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Keywords: Vitiligo
Tacrolimus
Face
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicentric French parallel double-blind randomized versus placebo study

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Subject male or female with age over 18 years old
2. Diagnosis of non-segmental (symmetrical) vitiligo
3. Presence of at least one vitiligo target-plaque on the face, with:

   Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration)
4. Subject affiliated to the French social security system

Exclusion Criteria:

1. Progressive vitiligo over the last 3 months
2. Spontaneous ongoing repigmentation (documented in the last 3 months)
3. Previous topical Tacrolimus treatment in the last 3 months
4. Previous topical or systemic treatment in the last month:

   Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator
5. Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments
6. Known sensitivity to study drug or macrolides
7. Past history of skin cancer or lymphoma
8. Congenital or acquired immunodeficiency
9. Pregnant or breastfeeding women
10. Women without contraception
11. Absence of signed informed consent

Primary outcomes:
measure: Percentage of repigmented surface area of the target lesion ≥75%
timeFrame: One year
Secondary outcomes:
measure: Variation in percentage of repigmented surface area
timeFrame: 24 weeks
measure: Variation in percentage of repigmented surface area
timeFrame: 48 weeks
measure: Variation of patient's global satisfaction using Likert score
timeFrame: 12 weeks
measure: Variation of patient's global satisfaction using Likert score
timeFrame: 24 weeks
measure: Variation of patient's global satisfaction using Likert score
timeFrame: 48 weeks
measure: Variation of the physician global evaluation of treatment efficacy
timeFrame: 12 weeks
measure: Variation of the physician global evaluation of treatment efficacy
timeFrame: 24 weeks
measure: Variation of the physician global evaluation of treatment efficacy
timeFrame: 48 weeks
measure: Variation of the Dermatology Life Quality Index
timeFrame: 24 weeks
measure: Number of participants with Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - St André Hospital
city: Le Mans
country: France
facility: Regional Hospital Center of Le Mans -
city: Nice
country: France
facility: University Hospital Center of Nice - Hôpital de l'Archet
city: Rennes
country: France
facility: University Hospital Center of Rennes - Hôpital Pontchaillou
Study officials:
affiliation: University Hospital Bordeaux, France
name: Khaled EZZEDINE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.