Clinical trial NCT04440371: Phototherapy Combination With Topicals in Vitiligo
Official title: Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo, Generalized
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: efficacy of treatment
timeFrame: Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
measure: Efficacy of treatment
timeFrame: 3 months post treatment
measure: Efficacy of treatment
timeFrame: 6 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Diala Alshiyab
Study officials:
affiliation: Jordan University of Science and Technology
name: Diala Alshiyab, MD
role: PRINCIPAL_INVESTIGATOR
References: