NCT04440371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 21, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

3.1 years

First QC Date

May 28, 2020

Last Update Submit

September 10, 2022

Conditions

Vitiligo, Generalized

Outcome Measures

Primary Outcomes (3)

  • 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 .

    Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage

  • 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.

    3 months post treatment

  • 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.

    6 months post treatment

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

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

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

calcipotriol / betamethasone

ACTIVE COMPARATOR

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

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

Interventions

Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weeklyCOMBINATION_PRODUCT

Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)

Tacrolimuscalcipotriol / betamethasone
Calcipotriol/Betamethasone ointment plus NBUVBCOMBINATION_PRODUCT

Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly

Tacrolimuscalcipotriol / betamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diala Alshiyab

Irbid, Jordan

Location

Related Publications (1)

  • Alshiyab D, Al-Qarqaz F, Ba-Shammakh S, Al-Fakih A, Altawalbeh A, Alsheyab S, Sarakbi D, Muhaidat J. Comparison of the efficacy of tacrolimus 0.1% ointment vs calcipotriol/betamethasone in combination with NBUVB in treatment of vitiligo. J Dermatolog Treat. 2023 Dec;34(1):2252119. doi: 10.1080/09546634.2023.2252119.

    PMID: 37644869DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

Tacrolimuscalcipotriene

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Diala Alshiyab, MD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 19, 2020

Study Start

June 21, 2020

Primary Completion

July 30, 2023

Study Completion

December 30, 2023

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

JO(1)