Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT02466997
• Date of registration: 26/05/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Bordeaux
• Public title: Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC VITAC
• Scientific title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
• Date of first enrolment: February 23, 2016
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02466997
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Khaled EZZEDINE
• Affiliation: University Hospital Bordeaux, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vitiligo

Intervention(s)

Drug: Placebo

Drug: tacrolimus

Primary Outcome(s)

Percentage of repigmented surface area of the target lesion =75% [Time Frame: One year]

Secondary Outcome(s)

Variation of patient's global satisfaction using Likert score [Time Frame: 24 weeks]

Variation of the physician global evaluation of treatment efficacy [Time Frame: 48 weeks]

Variation of patient's global satisfaction using Likert score [Time Frame: 12 weeks]

Variation of patient's global satisfaction using Likert score [Time Frame: 48 weeks]

Variation in percentage of repigmented surface area [Time Frame: 48 weeks]

Variation of the Dermatology Life Quality Index [Time Frame: 24 weeks]

Variation of the physician global evaluation of treatment efficacy [Time Frame: 12 weeks]

Variation of the physician global evaluation of treatment efficacy [Time Frame: 24 weeks]

Number of participants with Adverse events [Time Frame: 24 weeks]

Variation in percentage of repigmented surface area [Time Frame: 24 weeks]

Secondary ID(s)

CHUBX 2012/05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors