Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358082
• Other study ID #: Tacvit01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 12, 2017
• Last updated: November 29, 2017
• Start date: October 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: November 2017
• Source: Sohag University
• Contact: Aml Ahmed, MBBCH
• Phone: 01093801703
• Email: hanodymody12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tacrolimus
• Vitiligo

Intervention

Drug:
• Tacrolimus 0.03% Ointment
topical tacrolimus 0.03% twice daily for 6 months
• Hydrocortisone Acetate 1% Ointment
hydrocortisone acetate 1% ointment twice daily for 6 months

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo Area Scoring Index (VASI)	The percentage of vitiligo involvement for each body region is calculated by using the palmar method. The palmar method uses the palmar surface area of the patient's hand as an estimation guide and defines the surface of the patient's hand including fingers to be 1% of the total body surface area.; The extent of residual depigmentation is expressed by the following percentages: 0, 10%, 25%, 50%, 75%, 90%, or 100%.; At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; at 10%, only specks of depigmentation are present.; VASI= ? [HAND UNITS] × [RESIDUAL DEPIGMENTATION].	basline to 9 months
Secondary	Vitiligo Disease Activity (VIDA) Score	): is a six-point scale for evaluating vitiligo activity.; In this score grading is based on disease activity and time period. Grading is as follows: + 4: (activity lasting 6 weeks or less); score +3: (activity lasting 6 weeks to 3 months); score 2: (activity lasting 3-6 months); score1: (activity lasting 6-12 months); score 0: (stable for 1 year or more); score -1: (stable with spontaneous repigmentation for 1 year or more).; A low Vitiligo disease activity score indicate less vitiligo activity.	baseline to 9 months