search
Back to results

Phototherapy Combination With Topicals in Vitiligo (NBUVB)

Primary Purpose

Vitiligo, Generalized

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly
Calcipotriol/Betamethasone ointment plus NBUVB
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo, Generalized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diala Alshiyab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tacrolimus

calcipotriol / betamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2020
Last Updated
September 10, 2022
Sponsor
Jordan University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04440371
Brief Title
Phototherapy Combination With Topicals in Vitiligo
Acronym
NBUVB
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus
Arm Type
Active Comparator
Arm Description
Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day
Arm Title
calcipotriol / betamethasone
Arm Type
Active Comparator
Arm Description
Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day
Intervention Type
Combination Product
Intervention Name(s)
Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly
Intervention Description
Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
Intervention Type
Combination Product
Intervention Name(s)
Calcipotriol/Betamethasone ointment plus NBUVB
Intervention Description
Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
Primary Outcome Measure Information:
Title
efficacy of treatment
Description
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 .
Time Frame
Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
Title
Efficacy of treatment
Description
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.
Time Frame
3 months post treatment
Title
Efficacy of treatment
Description
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.
Time Frame
6 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diala Alshiyab, MD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diala Alshiyab
City
Irbid
Country
Jordan

12. IPD Sharing Statement

Learn more about this trial

Phototherapy Combination With Topicals in Vitiligo

We'll reach out to this number within 24 hrs