NCT03358082

Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitiligo
• Tacrolimus

Interventions

Type	Name	Description
DRUG	Tacrolimus 0.03% Ointment	topical tacrolimus 0.03% twice daily for 6 months
DRUG	Hydrocortisone Acetate 1% Ointment	hydrocortisone acetate 1% ointment twice daily for 6 months

Timeline

• Start date: 2017-10-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2017-11-30
• Last updated: 2017-11-30

Locations

1 site across 1 country: Egypt