Phototherapy Combination With Topicals in Vitiligo (NBUVB)

Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo

Patients will be included in a randomized controlled clinical trial, will enroll only adult vitiligo patients with surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitiligo, Generalized
• Intervention / Treatment: Combination product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly; Combination product: Calcipotriol/Betamethasone ointment plus NBUVB

Detailed Description

Patients to be included in this randomized controlled study are adults with generalized vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo. In our going study, adult patients will be enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3 sessions per week in combination with one of the following randomly; one group will start on Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol & betamethasone containing cream once daily, photos will be taken and the exact sites involved will be detected, efficacy of treatment will be assessed according to repigmentation percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months compared to baseline will be classified into 5 groups according to the percentage of repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal (1%-25%); or no response.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Diala Alshiyab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Adult patients ( ≥ 18 years).
• Diagnosed with vitiligo clinically and by using wood's light
• Generalized type vitiligo and BSA ≥ 10%
• Planned by his physician to start on phototherapy
• Wash off period for patients on treatment of one month duration.

Exclusion criteria:

• Children less than 18 year old
• Localized type vitiligo or BSA less than 10%
• Unable to do phototherapy
• Pregnant women with vitiligo
• Previously failed to response to phototherapy

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: Tacrolimus; Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day	Combination product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly; Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm); Combination product: Calcipotriol/Betamethasone ointment plus NBUVB; Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
Active Comparator: calcipotriol / betamethasone; Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day	Combination product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly; Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm); Combination product: Calcipotriol/Betamethasone ointment plus NBUVB; Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA) at baseline. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken .	Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
Efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA) at 3 months. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.	3 months post treatment
Efficacy of treatment	The area of vitiligo will be measured using body surface area (BSA). the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken.	6 months post treatment

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Diala Alshiyab, MD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2020
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

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; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Calcineurin Inhibitors; Betamethasone; Calcipotriene; Tacrolimus
• Other Study ID Numbers: 21/104/2017

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.: No