Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

S

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)

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

Trial contacts and locations

0

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Central trial contact

Aml Ahmed, MBBCH; Ramadan Saleh, MD

Data sourced from clinicaltrials.gov

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