NCT04440371

Phototherapy Combination With Topicals in Vitiligo

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Vitiligo, Generalized

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-06-21
• Primary completion: 2023-07-30
• Completion: 2023-12-30
• First posted: 2020-06-19
• Last updated: 2022-09-13

Locations

1 site across 1 country: Jordan