Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

Phase 1

• Conditions: Vitiligo; Tacrolimus
• Interventions: Drug: Tacrolimus 0.03% Ointment; Drug: Hydrocortisone Acetate 1% Ointment

• Registration Number: NCT03358082
• Lead Sponsor: Sohag University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Primary Completion: 2018-12-01
• Study Completion: 2019-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus group	Tacrolimus 0.03% Ointment	Tacrolimus 0.03% ointment twice daily for 6 months
Hydrocortisone group	Hydrocortisone Acetate 1% Ointment	hydrocortisone acetate 1% ointment twice daily for 6 months

Primary Outcome Measures

Name	Time	Method
Vitiligo Area Scoring Index (VASI)	basline to 9 months	* 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= ∑ \[HAND UNITS\] × \[RESIDUAL DEPIGMENTATION\].

Secondary Outcome Measures

Name	Time	Method
Vitiligo Disease Activity (VIDA) Score	baseline to 9 months	): 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.

Trial Locations

Locations (1)

Sohag University; 🇪🇬 Sohag, Egypt