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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Variation in percentage of repigmented surface area |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Khaled EZZEDINE | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bordeaux - St André Hospital | Bordeaux | 33000 | France | |||
| Regional Hospital Center of Le Mans - |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33549606 | Derived | 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. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| D019066 | Facies |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of participants with Adverse events | 24 weeks |
| Le Mans |
| 72000 |
| France |
| University Hospital Center of Nice - Hôpital de l'Archet | Nice | 06000 | France |
| University Hospital Center of Rennes - Hôpital Pontchaillou | Rennes | 35000 | France |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |