VitiligoPhase 1NB-UVBNCT07044141
Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo
A Phase 1 study testing Azathioprine and Tofacitinib in people with Vitiligo, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine . 10 will be given tofacitinib Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Azathioprine and Tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient of vitiligo with any VASI both genders 18 to 60yrs
Who cannot join
- pregnancy/lactation Hyerlipidrmia Patient on immunemodulator Histry pf tuberculosis Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Oral Tofacitinib in Combination With Narrow Band UVB in the Treatment of Vitiligo
20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine . 10 will be given tofacitinib
Read the detailed description
Total 20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine 50mg twice daily. 10 will be given tofacitinib 5mg twice daily. For 6 months
- Conditions
- Vitiligo
- Being tested
- Azathioprine, Tofacitinib
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzathioprineDrug
azathioprine 50mg twice daily will be given
TofacitinibDrug
It is a janus kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Azathioprine is an immunomodulator used in treatment of vitiligo Receives: Drug: Azathioprine |
| Group B | Active comparator | Tofacitinib It is a Janu kinase pathway inhibitor Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASI improvement upto 50%
Study will be considered efficacious if 50% improvement in VASI from baseline is seen by end of 6 months of study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr ayesha wahid, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044141
- Sponsor's protocol ID
- Dermatology LGH
- Acronym
- NB-UVB
- Status last verified
- May 2025
- First submitted
- 23 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Tofacitinib in Combination With Narrow Band UVB in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT07044141
- Acronym / sponsor ID
- NB-UVB / Dermatology LGH
- Conditions
- Vitiligo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Jun 2025 (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.
20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine . 10 will be given tofacitinib
Detailed description
Total 20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine 50mg twice daily. 10 will be given tofacitinib 5mg twice daily. For 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: AzathioprineAzathioprine is an immunomodulator used in treatment of vitiligo |
| Group B | Active comparator | Drug: TofacitinibTofacitinib It is a Janu kinase pathway inhibitor |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient of vitiligo with any VASI both genders 18 to 60yrs
Key exclusion criteria (1 listed)
- pregnancy/lactation Hyerlipidrmia Patient on immunemodulator Histry pf tuberculosis Immunocompromised patients
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 |
|---|---|---|
| Azathioprineazathioprine 50mg twice daily will be given | Drug | Group A |
| TofacitinibIt is a janus kinase inhibitor | Drug | Group B |
Primary outcome
VASI improvement upto 50%
Time frame: 6 months
Study will be considered efficacious if 50% improvement in VASI from baseline is seen by end of 6 months of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azathioprine and Tofacitinib in people with Vitiligo, run by Lahore General Hospital at 1 site in Pakistan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
VASI improvement upto 50% (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.