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

Vitiligo Clinical Trial

— VITAC  

Official title:

Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466997
• Other study ID #: CHUBX 2012/05
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicentric French parallel double-blind randomized versus placebo study

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• tacrolimus
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
• Placebo

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	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)	24 weeks
Secondary	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)	48 weeks
Secondary	Variation of patient's global satisfaction using Likert score	Variation of patient's global satisfaction using Likert score at each follow-up visit	12 weeks
Secondary	Variation of patient's global satisfaction using Likert score	Variation of patient's global satisfaction using Likert score at each follow-up visit	24 weeks
Secondary	Variation of patient's global satisfaction using Likert score	Variation of patient's global satisfaction using Likert score at each follow-up visit	48 weeks
Secondary	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	12 weeks
Secondary	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.	24 weeks
Secondary	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.	48 weeks
Secondary	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	24 weeks
Secondary	Number of participants with Adverse events		24 weeks

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