Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo

The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months .All types of vitiligo will be included except universal vitiligo.

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Radiation: NB-UVB; Combination product: NB-UVB & Tacrolimus 0.03%

Detailed Description

Study approval:

The study will be submitted for approval by the Scientific and Ethical Committees at Faculty of Medicine, South Valley University, Qena. An informed written consent will be obtained from all participants.

Study design:

A randomized controlled trial.

Study population:

The study will include patients who attend the outpatient Clinic of Dermatology, Venereology and Andrology, Faculty of Medicine, South Valley University, with clinical diagnosis of vitiligo. Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity will be excluded.

Methods:

• Wash out period: ( 4 weeks) During this period, initial medical evaluation will be performed, social demographic data will be collected and patients will be enrolled after obtaining a written consent.
• Test period: (6 months) *Randomization: at the initial visit (visit 0), following the wash out period and before the start of treatment, patients will be randomly assigned to 2 treatment groups; Group (A) : patients will receive NB-UVB sessions twice weekly for 6 months. Initial dose will be 100 mJ/cm2, the dose will be increased by 10% per session.

Group (B) : patients will receive NB-UVB sessions twice weekly for 6 months with the same dose plus topical application of tacrolimus 0.03% ointment twice dialy for the first month of treatment and once dialy for the rest 5 months of treatment.

All Patients will be evaluated before the start of treatment (visit 0) and at monthly intervals for 6 months.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • Recruiting
    • South Valley University
    • Contact: Noha Samir, MBBCh; Phone Number: 01001248106; Email: noha_samir89@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients with clinical diagnosis of vitiligo.

Exclusion Criteria:

• Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (NB-UVB); Intervention: patients will be treated with Narrow band ultra violet rays alone for 6 months	Radiation: NB-UVB; NB-UVB given twice weekly for 6 months
Active Comparator: Group B ( combined NB-UVB & Tacrolimus); Intervention: patients will be treated with NB-UVB & Tacrolimus 0.03 % ointment for 6 months	Combination product: NB-UVB & Tacrolimus 0.03%; NB-UVB given twice weekly for 6 months and tacrolimus 0.03 % ointment given for twice daily for the first month of treatment and once daily for the rest 5 months of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitiligo Area Scoring Index (VASI)	The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites [Hand Units] ´ [Residual depigmentation].	baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitiligo Disease Activity (VIDA) score	The VIDA is a six-point scale for assessing vitiligo activity. Scoring is based on the individual's own opinion of the present disease activity over time. Active vitiligo involves either expansion of existing lesions or appearance of new lesions. Grading is as follows: VIDA Score +4 - Activity of 6 weeks or less duration; +3 - Activity of 6 weeks to 3 months; +2 - Activity of 3 - 6 months;+1 - Activity of 6 - 12 months; 0 - Stable for 1 year or more; and -1 - Stable with spontaneous repigmentation since 1 year or more. A low VIDA score indicates less activity.	baseline to 9 months

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Director: Ramdan Saleh, MD, Sohag Faculty of Medicine, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: tcrnbvtlg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes