Vitiligo, GeneralizedNBUVBNCT04440371
Phototherapy Combination With Topicals in Vitiligo
A study testing Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly and Calcipotriol/Betamethasone ointment plus NBUVB in people with Vitiligo, Generalized, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo, Generalized
- What is being tested?
- Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly and Calcipotriol/Betamethasone ointment plus NBUVB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteJordan
- Study dates
- 21 Jun 2020to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo
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.
Read the 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.
- Conditions
- Vitiligo, Generalized
- Being tested
- Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly, Calcipotriol/Betamethasone ointment plus NBUVB
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weeklyCombination product
Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
Calcipotriol/Betamethasone ointment plus NBUVBCombination product
Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Active comparator | Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day Receives: Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly; Combination 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 Receives: Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly; Combination Product: Calcipotriol/Betamethasone ointment plus NBUVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: 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.
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start21 Jun 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitiligo, GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diala Alshiyab, MD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440371
- Sponsor's protocol ID
- 21/104/2017
- Acronym
- NBUVB
- Status last verified
- Sep 2022
- First submitted
- 28 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37644869
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT04440371
- Acronym / sponsor ID
- NBUVB / 21/104/2017
- Conditions
- Vitiligo, Generalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Active comparator | Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly, Combination Product: Calcipotriol/Betamethasone ointment plus NBUVBPhototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day |
| calcipotriol / betamethasone | Active comparator | Combination Product: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly, Combination Product: Calcipotriol/Betamethasone ointment plus NBUVBPhototherapy NBUVB will be given 3 times per week and calcipotriol \& betamethasone containing cream will be applied once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weeklyTacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm) | Combination product | Tacrolimus, calcipotriol / betamethasone |
| Calcipotriol/Betamethasone ointment plus NBUVBCalcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly | Combination product | Tacrolimus, calcipotriol / betamethasone |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 37644869Alshiyab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diala Alshiyab, MD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly and Calcipotriol/Betamethasone ointment plus NBUVB in people with Vitiligo, Generalized, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of treatment (time frame: Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.