VitiligoNCT07088276
Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo.
A study testing microneedling with topical crisaborole in people with Vitiligo, run by Tanta University.
Trial summary
The goal of this clinical trial is to learn if topical crisaborole ointment works to treat vitiligo. It will also learn about the safety of the drug. The main questions it aims to answer are: Can the drug cause repigmentation of vitiligo lesions when used as topical form after microneedling? What medical problems do… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitiligo
- What is being tested?
- microneedling with topical crisaborole
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffer from non-segmental stable vitiligo.
- Patients who will accept to be included in the study and will sign a written consent.
Who cannot join
- Patients with history of koebnerization or any sign of disease activity.
- Patients with keloid tendency.
- Patients with active infection.
- Pregnant or lactating woman.
About this study
Official title: Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo. A Prospective Controlled Trial.
The goal of this clinical trial is to learn if topical crisaborole ointment works to treat vitiligo. It will also learn about the safety of the drug. The main questions it aims to answer are:
Can the drug cause repigmentation of vitiligo lesions when used as topical form after microneedling? What medical problems do participants have when the drug used?
Participants will:
Visit the clinic once every 2 weeks to have the microneedling sessions for 3 months. and also they will have narrow band UVB sessions two times per week.
Record any side effect they have during or after the sessions.
- Conditions
- Vitiligo
- Being tested
- microneedling with topical crisaborole
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling with topical crisaboroleProcedure or surgery
From each patient 3 patches will be selected The first will have microneedling and topical crisaborole and NB UVB sessions The second will have microneedling and NB UVB sessions The third will be exposed only to NB UVB sessions The microneedling sessions will be every 2 weeks for 6 sessions
| Study group | Role | What they receive |
|---|---|---|
| the main patch with microneedling and topical crisaborole and two patches as control | Other | each patient will have 3 vitiligo patches one will be treated by microneedling and topical application of crisaborole and the other 2 patches will be considered as control patches Receives: Procedure: microneedling with topical crisaborole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation of vitiligo lesions
The repigmentation responses will be expressed qualitatively as the following No change (0%-25%) = mild improvement (26%-50%) = moderate improvement (51%-75%) = good improvement (76%-100%) = excellent improvement
Measured: 3 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (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.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Hassan Moustafa Fahmy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088276
- Sponsor's protocol ID
- 36264MS976/6/25
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo. A Prospective Controlled Trial.
- ClinicalTrials.gov ID
- NCT07088276
- Acronym / sponsor ID
- 36264MS976/6/25
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Jul 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.
The goal of this clinical trial is to learn if topical crisaborole ointment works to treat vitiligo. It will also learn about the safety of the drug. The main questions it aims to answer are:
Can the drug cause repigmentation of vitiligo lesions when used as topical form after microneedling? What medical problems do participants have when the drug used?
Participants will:
Visit the clinic once every 2 weeks to have the microneedling sessions for 3 months. and also they will have narrow band UVB sessions two times per week.
Record any side effect they have during or after the sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the main patch with microneedling and topical crisaborole and two patches as control | Other | Procedure: microneedling with topical crisaboroleeach patient will have 3 vitiligo patches one will be treated by microneedling and topical application of crisaborole and the other 2 patches will be considered as control patches |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffer from non-segmental stable vitiligo.
- Patients who will accept to be included in the study and will sign a written consent.
Key exclusion criteria (4 listed)
- Patients with history of koebnerization or any sign of disease activity.
- Patients with keloid tendency.
- Patients with active infection.
- Pregnant or lactating woman.
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 |
|---|---|---|
| microneedling with topical crisaboroleFrom each patient 3 patches will be selected The first will have microneedling and topical crisaborole and NB UVB sessions The second will have microneedling and NB UVB sessions The third will be exposed only to NB UVB sessions The microneedling sessions will be every 2 weeks for 6 sessions | Procedure or surgery | the main patch with microneedling and topical crisaborole and two patches as control |
Primary outcome
Repigmentation of vitiligo lesions
Time frame: 3 months from the start of treatment
The repigmentation responses will be expressed qualitatively as the following No change (0%-25%) = mild improvement (26%-50%) = moderate improvement (51%-75%) = good improvement (76%-100%) = excellent improvement
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 30 Jul 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.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling with topical crisaborole in people with Vitiligo, run by Tanta University.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Repigmentation of vitiligo lesions (time frame: 3 months from the start 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 30 Jul 2025.