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Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

NCT ID: NCT03358082

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-02-01

Brief Summary

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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

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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

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Vitiligo Tacrolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus group

Tacrolimus 0.03% ointment twice daily for 6 months

Group Type ACTIVE_COMPARATOR

Tacrolimus 0.03% Ointment

Intervention Type DRUG

topical tacrolimus 0.03% twice daily for 6 months

Hydrocortisone group

hydrocortisone acetate 1% ointment twice daily for 6 months

Group Type ACTIVE_COMPARATOR

Hydrocortisone Acetate 1% Ointment

Intervention Type DRUG

hydrocortisone acetate 1% ointment twice daily for 6 months

Interventions

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Tacrolimus 0.03% Ointment

topical tacrolimus 0.03% twice daily for 6 months

Intervention Type DRUG

Hydrocortisone Acetate 1% Ointment

hydrocortisone acetate 1% ointment twice daily for 6 months

Intervention Type DRUG

Other Intervention Names

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Tarolimus ointment Texacort ointment

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Aml Abd Elaziz Ahmed

Dermatology Resident in Farshot General Hospital, Qena, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan Saleh, MD

Role: STUDY_DIRECTOR

Sohag Faculty of Medicine, Sohag University

Locations

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Sohag University

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aml Ahmed, MBBCH

Role: CONTACT

Phone: 01093801703

Email: [email protected]

Ramadan Saleh, MD

Role: CONTACT

Phone: 01005423054

Email: [email protected]

Facility Contacts

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Aml Ahmed, MBBCH

Role: primary

Ramadan Saleh, MD

Role: backup

Other Identifiers

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Tacvit01

Identifier Type: -

Identifier Source: org_study_id