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

NCT02466997 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2012/05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

Multicentric French parallel double-blind randomized versus placebo study

Conditions

Vitiligo

Keywords

Vitiligo; Tacrolimus; Face

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Variation in percentage of repigmented surface area

  24 weeks

• Variation in percentage of repigmented surface area

  48 weeks

• Variation of patient's global satisfaction using Likert score

  12 weeks

• Variation of patient's global satisfaction using Likert score

  24 weeks

• Variation of patient's global satisfaction using Likert score

  48 weeks

Study Arms (2)

Tacrolimus group

EXPERIMENTAL

Target-lesion will be treated with the study treatment BID. The batch of treatment (Tacrolimus ointment 0.1% or placebo) will be randomized. All the patients will be treated during 6 months. Counselling on natural daylight exposition will also be given to all patients. During the 6-month observation period, relapse (worsening of VASI ≥ 25%) will be re-treated by the study treatment

Drug: tacrolimus

Control group

PLACEBO COMPARATOR

In the Control group, patients will receive the placebo ointment to be applied twice a day during 24 weeks. Counselling on natural light exposure during the duration of the trial will be given.

Drug: Placebo

Interventions

tacrolimus DRUG

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

Also known as: Protopic

Tacrolimus group

Placebo DRUG

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject male or female with age over 18 years old
• Diagnosis of non-segmental (symmetrical) vitiligo
• 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)
• Subject affiliated to the French social security system

You may not qualify if:

• Progressive vitiligo over the last 3 months
• Spontaneous ongoing repigmentation (documented in the last 3 months)
• Previous topical Tacrolimus treatment in the last 3 months
• 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
• Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments
• Known sensitivity to study drug or macrolides
• Past history of skin cancer or lymphoma
• Congenital or acquired immunodeficiency
• Pregnant or breastfeeding women
• Women without contraception
• Absence of signed informed consent

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

University Hospital of Bordeaux - St André Hospital

Bordeaux, 33000, France

Location

Regional Hospital Center of Le Mans -

Le Mans, 72000, France

Location

University Hospital Center of Nice - Hôpital de l'Archet

Nice, 06000, France

Location

University Hospital Center of Rennes - Hôpital Pontchaillou

Rennes, 35000, France

Location

Related Publications (1)

• 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.

  PMID: 33549606 DERIVED

MeSH Terms

Conditions

Vitiligo; Facies

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Khaled EZZEDINE

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 9, 2015
• Study Start: February 23, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

FR (4)