Vitiligo - Macular DepigmentationEarly Phase 1NB-UVBNCT06880042
COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH 0.1% TACROLIMUS VS NARROWBAND UVB WITH 0.005% CALCIPOTRIOL IN TREATMENT OF VITILIGO
A Early Phase 1 study testing Tacrolimus and Calcipotriol in people with Vitiligo - Macular Depigmentation and Tacrolimus, run by Dr ayesha wahid at 1 site in Pakistan.
Trial summary
Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo - Macular Depigmentation, Tacrolimus
- What is being tested?
- Tacrolimus and Calcipotriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 30 Aug 2025
- Phase
- Early 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Localized vitiligo Age 15 to 70years Body surface upto 20% Stable more than 3 months
Who cannot join
- • Pregnant or lactating female patients.
- Skin malignancy or any other malignant skin condition.
- Photo induced or photo aggravated dermatosis like (SLE, photodermatitis, rosacea, psoriasis, pemphigus vulgaris) along with vitiligo.
- Prior history of allergy to tacrolimus or calcipotriol.
- Other form of treatment for vitiligo within at least 1 month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed
Read the detailed description
Evaulation of efficacy and safety of narrowband uvb and tacrolimus and NBUVB and calcipotriol in patient if stable vitiligo with body surface area less than 20% It will be assessed by VASI score and VIisual analogie scale
- Conditions
- Vitiligo - Macular Depigmentation, Tacrolimus
- Being tested
- Tacrolimus, Calcipotriol
- Keywords
- Vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus is calcineurin inhibitor that will act as immunomodulator
CalcipotriolDrug
Calcipotriol is a vitamin D analogue that will act as immunomodulator
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Active comparator | Patient of Limited vitiligo less than 20% BSA will be treated with topical tacrolimus and narrowband UVB Receives: Drug: Tacrolimus |
| Calcipotriol | Active comparator | Calcipotriol is a vitamin D analogue that will act as immunomodulator Receives: Drug: Calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASI improvement upto 50%
Improvement in VASI score upto 50%
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 May 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo - Macular DepigmentationStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr ayesha wahid
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr ayesha wahid, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880042
- Sponsor's protocol ID
- LGH
- Acronym
- NB-UVB
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH 0.1% TACROLIMUS VS NARROWBAND UVB WITH 0.005% CALCIPOTRIOL IN TREATMENT OF VITILIGO
- ClinicalTrials.gov ID
- NCT06880042
- Acronym / sponsor ID
- NB-UVB / LGH
- Conditions
- Vitiligo - Macular Depigmentation, Tacrolimus
- Keywords
- Vitiligo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr ayesha wahidOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Mar 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.
Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed
Detailed description
Evaulation of efficacy and safety of narrowband uvb and tacrolimus and NBUVB and calcipotriol in patient if stable vitiligo with body surface area less than 20% It will be assessed by VASI score and VIisual analogie scale
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 | Drug: TacrolimusPatient of Limited vitiligo less than 20% BSA will be treated with topical tacrolimus and narrowband UVB |
| Calcipotriol | Active comparator | Drug: CalcipotriolCalcipotriol is a vitamin D analogue that will act as immunomodulator |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Localized vitiligo Age 15 to 70years Body surface upto 20% Stable more than 3 months
Key exclusion criteria (5 listed)
- • Pregnant or lactating female 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 |
|---|---|---|
| TacrolimusTacrolimus is calcineurin inhibitor that will act as immunomodulator | Drug | Tacrolimus |
| CalcipotriolCalcipotriol is a vitamin D analogue that will act as immunomodulator | Drug | Calcipotriol |
Primary outcome
VASI improvement upto 50%
Time frame: 3 months
Improvement in VASI score upto 50%
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 24 Jun 2025.
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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.
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 Early Phase 1 study testing Tacrolimus and Calcipotriol in people with Vitiligo - Macular Depigmentation and Tacrolimus, run by Dr ayesha wahid 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 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: enrolling by invitation, as of the sponsor's last update on 24 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: 3 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 24 Jun 2025.