Phototherapy Combination With Topicals in Vitiligo (NBUVB)

Jordan University of Science and Technology

Status: Active, not recruiting

Conditions: Vitiligo, Generalized

Treatments: Combination Product: Calcipotriol/Betamethasone ointment plus NBUVB; Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT04440371

21/104/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day

Treatment:

Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly

Combination Product: Calcipotriol/Betamethasone ointment plus NBUVB

calcipotriol / betamethasone

Active Comparator group

Description:

Phototherapy NBUVB will be given 3 times per week and calcipotriol \& betamethasone containing cream will be applied once a day

Treatment:

Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly

Combination Product: Calcipotriol/Betamethasone ointment plus NBUVB