Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

Sohag University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Tacrolimus; Vitiligo

Treatments: Drug: Tacrolimus 0.03% Ointment; Drug: Hydrocortisone Acetate 1% Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03358082

Tacvit01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tacrolimus group

Active Comparator group

Description:

Tacrolimus 0.03% ointment twice daily for 6 months

Treatment:

Drug: Tacrolimus 0.03% Ointment

Hydrocortisone group

Active Comparator group

Description:

hydrocortisone acetate 1% ointment twice daily for 6 months

Treatment:

Drug: Hydrocortisone Acetate 1% Ointment