VitiligoNCT07532330
Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo
A study testing Narrowband UVB Phototherapy, Topical Tacrolimus 0.1% ointment and Topical Tyrosine 2% cream in people with Vitiligo, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if adding topical tacrolimus or topical tyrosine to narrowband UVB phototherapy works to treat vitiligo in adults. It will also learn about the safety of both combinations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Narrowband UVB Phototherapy, Topical Tacrolimus 0.1% ointment and Topical Tyrosine 2% cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 15 Apr 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years with vitiligo who are candidates for narrowband UVB (NB-UVB) phototherapy.
Who cannot join
- Pregnant or lactating women.
- Patients who have received any systemic or topical treatment for vitiligo within the preceding three months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minia Tertiary University Hospital, Faculty of Medicine, Minia University, Minia, Egypt.
Minya, Minya Governorate, 61519
About this study
Official title: Comparative Efficacy of Topical Tacrolimus Versus Tyrosine as Co-Therapy to NB-UVB in Vitiligo: A Randomized Intra-Individual Controlled Clinical Trial
The goal of this clinical trial is to learn if adding topical tacrolimus or topical tyrosine to narrowband UVB phototherapy works to treat vitiligo in adults. It will also learn about the safety of both combinations.
The main questions it aims to answer are:
Read more
Which combination (UVB + tacrolimus or UVB + tyrosine) leads to greater skin repigmentation (color return) after 3 months of treatment? What side effects do participants experience with each combination? Researchers will compare three groups: UVB + tacrolimus, UVB + tyrosine, and UVB only to see which is more effective and safer.
Participants will:
Receive narrowband UVB phototherapy sessions two times per week at minimal erythema dose Apply either topical tacrolimus or topical tyrosine to their vitiligo patches twice daily Visit the clinic every one month for skin examination and photography Report any side effects or skin reactions
Read the detailed description
Study Design and Setting:
This is a randomized, intra-individual (within-patient) controlled, open-label clinical trial conducted at the outpatient dermatology clinic of a university hospital in Egypt. The study duration is from August 2025 to February 2026. A total of 69 patients with vitiligo were enrolled, with 67 completing the study.
For each enrolled patient, three comparable vitiligo patches were identified on the patient's body. Each patch was randomly assigned to one of three treatment regimens, allowing each patient to serve as their own control.
Phototherapy Procedure:
Narrowband UVB (NB-UVB) phototherapy was administered to all patches simultaneously using a full-body cabinet. Treatment was given twice weekly for 3 months, starting at the minimal erythema dose (MED) with incremental increases of 10-20% per session based on erythema response. The same phototherapy protocol was applied uniformly to all three patches on each patient.
Topical Treatments:
For patches assigned to combination therapy, the topical agent (either tyrosine 2% cream or tacrolimus 0.1% ointment) was applied by the patient at home twice daily (morning and evening) every day. Patches were clearly marked to the patients, and patients received standardized written instructions. Compliance was monitored by asking about remaining quantity of topical preparation at each follow-up visit.
Blinding and Assessment:
Although the trial was open-label for patients and treating physicians, outcome assessors were two independent dermatologists blinded to treatment allocation. Standardized digital photographs were taken under consistent lighting conditions at baseline and at 3 months. For each photograph and repigmentation percentage was determined via VESTA score.
Safety Monitoring:
At each phototherapy session (twice weekly), patients were assessed for acute adverse effects including erythema, pain, and pruritus (yes or no). Any adverse event requiring treatment interruption or discontinuation was recorded.
Data Management:
All data were collected on paper case report forms and then entered into an electronic database (Microsoft Excel) by independent data entry operator. The final dataset was exported to SPSS for analysis.
- Conditions
- Vitiligo
- Being tested
- Narrowband UVB Phototherapy, Topical Tacrolimus 0.1% ointment, Topical Tyrosine 2% cream
- Keywords
- vitiligo, phototherapy, narrowband UVB, tacrolimus, tyrosine
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVB PhototherapyDevice
Narrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation.
Topical Tacrolimus 0.1% ointmentDrug
Topical tacrolimus 0.1% ointment applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area.
Topical Tyrosine 2% creamDrug
Topical tyrosine 2% cream applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area.
| Study group | Role | What they receive |
|---|---|---|
| topical tyrosine 2% + NB-UVB | Experimental | Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months. Receives: Device: Narrowband UVB Phototherapy; Drug: Topical Tyrosine 2% cream |
| topical tacrolimus 0.1% + NB-UVB | Experimental | Narrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months. Receives: Device: Narrowband UVB Phototherapy; Drug: Topical Tacrolimus 0.1% ointment |
| NB-UVB only | Active comparator | Narrowband UVB phototherapy twice weekly plus placebo vehicle cream applied twice daily for 3 months. Receives: Device: Narrowband UVB Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement grade
Clinical improvement is categorized into four grades based on the percentage of repigmentation: Mild (<25% improvement), Moderate (25-50% improvement), Good (51-75% improvement), and Excellent (>75% improvement). Assessment is performed by two independent physicians using standardized photographs.
Measured: after 3 months of treatment
Secondary outcomes (2)
Change in VESTA Score from Baseline to month 3
The Vitiligo Extent Score by Target Area (VESTA) is a validated assessment tool that calculates the percentage of repigmentation within a target vitiligo patch. It accounts for both marginal and perifollicular repigmentation patterns. The score ranges from 0% (no repigmentation) to 100% (complete repigmentation). Higher scores indicate better treatment response.
Measured: Baseline and after 3 months of treatment
Incidence of Treatment-Related Adverse Events
Monitoring of local side effects including erythema, irritation, itching, and burning sensation at the application sites. Adverse events are recorded throughout the treatment period and graded for severity.
Measured: From baseline to month 3 (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Aug 2025
- Primary completion19 Feb 2026
- Study completion15 Apr 2026
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.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almostafa M Ahmed, MD, Minia University
- Investigators
- Almostafa M Ahmed, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532330
- Sponsor's protocol ID
- 1614/07/2025
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because participants did not provide informed consent for data sharing beyond the primary study purpose, and the study is a single-center trial with a small sample size conducted in a routine clinical setting.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Topical Tacrolimus Versus Tyrosine as Co-Therapy to NB-UVB in Vitiligo: A Randomized Intra-Individual Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07532330
- Acronym / sponsor ID
- 1614/07/2025
- Conditions
- Vitiligo
- Keywords
- vitiligo, phototherapy, narrowband UVB, tacrolimus, tyrosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 15 Apr 2026 (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.
The goal of this clinical trial is to learn if adding topical tacrolimus or topical tyrosine to narrowband UVB phototherapy works to treat vitiligo in adults. It will also learn about the safety of both combinations.
The main questions it aims to answer are:
Which combination (UVB + tacrolimus or UVB + tyrosine) leads to greater skin repigmentation (color return) after 3 months of treatment? What side effects do participants experience with each combination? Researchers will compare three groups: UVB + tacrolimus, UVB + tyrosine, and UVB only to see which is more effective and safer.
Participants will:
Receive narrowband UVB phototherapy sessions two times per week at minimal erythema dose Apply either topical tacrolimus or topical tyrosine to their vitiligo patches twice daily Visit the clinic every one month for skin examination and photography Report any side effects or skin reactions
Detailed description
Study Design and Setting:
This is a randomized, intra-individual (within-patient) controlled, open-label clinical trial conducted at the outpatient dermatology clinic of a university hospital in Egypt. The study duration is from August 2025 to February 2026. A total of 69 patients with vitiligo were enrolled, with 67 completing the study.
For each enrolled patient, three comparable vitiligo patches were identified on the patient's body. Each patch was randomly assigned to one of three treatment regimens, allowing each patient to serve as their own control.
Phototherapy Procedure:
Narrowband UVB (NB-UVB) phototherapy was administered to all patches simultaneously using a full-body cabinet. Treatment was given twice weekly for 3 months, starting at the minimal erythema dose (MED) with incremental increases of 10-20% per session based on erythema response. The same phototherapy protocol was applied uniformly to all three patches on each patient.
Topical Treatments:
For patches assigned to combination therapy, the topical agent (either tyrosine 2% cream or tacrolimus 0.1% ointment) was applied by the patient at home twice daily (morning and evening) every day. Patches were clearly marked to the patients, and patients received standardized written instructions. Compliance was monitored by asking about remaining quantity of topical preparation at each follow-up visit.
Blinding and Assessment:
Although the trial was open-label for patients and treating physicians, outcome assessors were two independent dermatologists blinded to treatment allocation. Standardized digital photographs were taken under consistent lighting conditions at baseline and at 3 months. For each photograph and repigmentation percentage was determined via VESTA score.
Safety Monitoring:
At each phototherapy session (twice weekly), patients were assessed for acute adverse effects including erythema, pain, and pruritus (yes or no). Any adverse event requiring treatment interruption or discontinuation was recorded.
Data Management:
All data were collected on paper case report forms and then entered into an electronic database (Microsoft Excel) by independent data entry operator. The final dataset was exported to SPSS for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| topical tyrosine 2% + NB-UVB | Experimental | Device: Narrowband UVB Phototherapy, Drug: Topical Tyrosine 2% creamNarrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months. |
| topical tacrolimus 0.1% + NB-UVB | Experimental | Device: Narrowband UVB Phototherapy, Drug: Topical Tacrolimus 0.1% ointmentNarrowband UVB phototherapy twice weekly plus topical tyrosine 2% cream applied twice daily for 3 months. |
| NB-UVB only | Active comparator | Device: Narrowband UVB PhototherapyNarrowband UVB phototherapy twice weekly plus placebo vehicle cream applied twice daily for 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-65 years with vitiligo who are candidates for narrowband UVB (NB-UVB) phototherapy.
Key exclusion criteria (2 listed)
- Pregnant or lactating women.
- Patients who have received any systemic or topical treatment for vitiligo within the preceding three months.
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 |
|---|---|---|
| Narrowband UVB PhototherapyNarrowband ultraviolet B (UVB) phototherapy administered twice weekly at minimal erythema dose for 3 months. Each session delivers 311-312 nm wavelength radiation. | Device | NB-UVB only, topical tacrolimus 0.1% + NB-UVB, topical tyrosine 2% + NB-UVB |
| Topical Tacrolimus 0.1% ointmentTopical tacrolimus 0.1% ointment applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area. | Drug | topical tacrolimus 0.1% + NB-UVB |
| Topical Tyrosine 2% creamTopical tyrosine 2% cream applied twice daily to the designated vitiligo patch for 3 months. Each application consists of a thin layer covering the entire patch area. | Drug | topical tyrosine 2% + NB-UVB |
Primary outcome
Clinical Improvement grade
Time frame: after 3 months of treatment
Clinical improvement is categorized into four grades based on the percentage of repigmentation: Mild (<25% improvement), Moderate (25-50% improvement), Good (51-75% improvement), and Excellent (>75% improvement). Assessment is performed by two independent physicians using standardized photographs.
2 secondary outcomes
Change in VESTA Score from Baseline to month 3
Time frame: Baseline and after 3 months of treatment
Incidence of Treatment-Related Adverse Events
Time frame: From baseline to month 3 (through study completion)
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 8 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because participants did not provide informed consent for data sharing beyond the primary study purpose, and the study is a single-center trial with a small sample size conducted in a routine clinical setting.
Related trials for Vitiligo
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
Vitiligo
RecruitingPhase 2
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Non-segmental Vitiligo
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.
Almostafa M Ahmed principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrowband UVB Phototherapy, Topical Tacrolimus 0.1% ointment and Topical Tyrosine 2% cream in people with Vitiligo, run by Minia University at 1 site in Egypt.
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 2 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 8 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 Egypt. 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?
Clinical Improvement grade (time frame: after 3 months of treatment). 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 8 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.