Phototherapy Combination With Topicals in Vitiligo

Overview

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 Title of Study: “Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2021

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Tacrolimus
    • Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day
  • Active Comparator: calcipotriol / betamethasone
    • Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day

Clinical Trial Outcome Measures

Primary Measures

  • efficacy of treatment
    • Time Frame: Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage
    • 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
    • Time Frame: 3 months post 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
    • Time Frame: 6 months post 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.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Jordan University of Science and Technology
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Diala Alshiyab, MD, Principal Investigator, Jordan University of Science and Technology
    • Overall Contact(s)
      • Diala Alshiyab, MD, 00962798608037, dmalshiyab@just.edu.jo

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