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Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
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.
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.
Age
2 - No limit years
Sex
ALL
Healthy Volunteers
No
Sohag University
Sohag, Egypt
Start Date
October 1, 2017
Primary Completion Date
December 1, 2018
Completion Date
February 1, 2019
Last Updated
November 30, 2017
100
ESTIMATED participants
Tacrolimus 0.03% Ointment
DRUG
Hydrocortisone Acetate 1% Ointment
DRUG
Lead Sponsor
Sohag University
NCT07431177
NCT07352293
NCT07437560
Data Source & Attribution
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