Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

Study Overview
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Brief Summary
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The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.

Detailed Description
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Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants. Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology & Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded. Patients and methods: Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months. Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.

Official Title
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Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial

Conditions
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Vitiligo, Tacrolimus

Intervention / Treatment
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* Drug: Tacrolimus 0.03% Ointment
* Drug: Hydrocortisone Acetate 1% Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients with clinical diagnosis of vitiligo Exclusion Criteria: children =or <2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus group<br>Tacrolimus 0.03% ointment twice daily for 6 months | Drug: Tacrolimus 0.03% Ointment<br>* topical tacrolimus 0.03% twice daily for 6 months<br>* Other names: Tarolimus ointment;|
| Active Comparator: Hydrocortisone group<br>hydrocortisone acetate 1% ointment twice daily for 6 months | Drug: Hydrocortisone Acetate 1% Ointment<br>* hydrocortisone acetate 1% ointment twice daily for 6 months<br>* Other names: Texacort ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitiligo Area Scoring Index (VASI) | The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area. The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%. At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present. VASI= ∑ [HAND UNITS] × [RESIDUAL DEPIGMENTATION]. | basline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitiligo Disease Activity (VIDA) Score | ): is a six-point scale for evaluating vitiligo activity. In this score grading is based on disease activity and time period. Grading is as follows: + 4: (activity lasting 6 weeks or less); score +3: (activity lasting 6 weeks to 3 months); score 2: (activity lasting 3-6 months); score1: (activity lasting 6-12 months); score 0: (stable for 1 year or more); score -1: (stable with spontaneous repigmentation for 1 year or more). A low Vitiligo disease activity score indicate less vitiligo activity. | baseline to 9 months |