VitiligoEarly Phase 1NCT07398807
Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo
A Early Phase 1 study testing Microneedling with 5-fluorouracil and Topical application of 0.05% Clobetasol propionate in people with Vitiligo, run by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn how well 5 fluorouracil (5FU) with micro-needling works to treat limited vitiligo as compared to strong steroid applied on skin. It will also learn about the safety of both these treatments. Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Microneedling with 5-fluorouracil and Topical application of 0.05% Clobetasol propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Aug 2025to Feb 2026
- 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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients willing to participate in the study
- Patients of age group of 05 -70 years.
- Vitiligo involving less than or equal to 10% body surface area.
Who cannot join
- Patients using or have used other treatments for vitiligo
- Pregnant women or lactating women
- Patients with unstable vitiligo
- Patients on immunosuppressant medications due to other diseases
- Patients having anemia, immunosuppression, bleeding disorder, taking anticoagulants or anti-platelet drugs or having epilepsy
- Patient having history of keloids or hypertrophic scars
- Patients with history of hypersensitivity to either of the drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Bahawalpur
Chak Eighty-seven -Twelve Left
KAINAT TARIQ, 03314030300, kainattariq555111@gmail.com
About this study
Official title: Effectiveness of Combining Micro Needling With 5 Fluorouracil Versus Potent Topical Steroids; in Treating Limited Vitiligo- Randomised Controlled Study
The goal of this clinical trial is to learn how well 5 fluorouracil (5FU) with micro-needling works to treat limited vitiligo as compared to strong steroid applied on skin. It will also learn about the safety of both these treatments. The main questions it aims to answer are:
- How well does 5FU with microneedling work to treat vitiligo by returning pigmentation in vitiligo patches as compared to steroid?
- What is participant's satisfaction when treated with 5FU with microneedling as compared to steroid?
- What skin problems do participants have when treated with FU with microneedling and steroid?
Read more
Researchers will compare 5FU with microneedling to steroid application to see how well both work to return pigment in vitiligo patches.
Participants will be divided into two groups. For Group A, 5 FU will be rubbed and absorbed on the vitiligo patch after micro-needling every 2 weeks.
For group B, topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches for 12 weeks.
Vitiligo patches will be assessed at the start of trial and then after 12 weeks of treatment.
Read the detailed description
The rationale of this study is to find a cost-effective treatment regime of 5 fluorouracil for limited stable vitiligo. We aim to compare how effective is the combination of micro-needling with 5 Fluorouracil versus topical potent steroids in the cases of stable, limited vitiligo (< 10% body surface area -BSA).
40 patients with limited vitiligo consulting the dermatologist in the hospital OPD will be included in the trial after application of the mentioned inclusion and exclusion criteria. After informed consent, a dermatologist will explain the required details of the procedure to the patients and give them their required treatment plan. They will be randomized into two groups by lottery method.
Demographic data like age, gender, location and number of vitiligo patches will be recorded along with baseline photograph and measurement of the vitiligo patches by VASI score.
In first group i.e., Group A, a topical eutectic mixture of local anesthetic in cream formulation (EMLA) will be applied over the patient's lesions for 30- 45 minutes. Lesion will be cleaned by pyodine iodine applied for at least 5 minutes. Micro-needling will be done by dr. Pen Ultima A6 with 42 needle cartridges (single usage) with 3mm depth and 2 passes will be made on the effected patch of vitiligo. Sterile gauze will be pressed on the lesion for 2 minutes to stop bleeding. Afterwards depth will be decreased to 1.5mm and 5 FU will be rubbed on the lesion before this step. Aim would be to facilitate percutaneous absorption of the drug with micro-needling. Micro-needling device will be held at 90-degree angle and will be glided up and down, followed by side to side and then diagonal sections with light pressure to avoid dragging. Few drops of 5 FU will be rubbed and absorbed again on the vitiligo patch after micro-needling. Not more than 0.5 ml 5FU will be used during each session. Lesions will be covered by a sterile dressing after the procedure. It will be removed after 12 hours. Patient will be instructed to avoid bathing for 24 hours after the procedure. 6 sessions will be done at 2 weeks interval.
Group B will be advised topical 0.05% clobetasol propionate ointment twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams. The application should be continued for 12 weeks.
A blinded independent medical observer will perform clinical assessment at the end of 12 weeks treatment period using the VASI score and using the following grading scale for all 40 patients: 1, < 25% minimal regain of pigment in the lesion; 2, 26-50% mild regain of pigment in the lesion; 3, 51-75% moderate regain of pigment in the lesion; 4, >75% excellent regain of pigment in the lesion.
Patient satisfaction will also be assessed by grading scale i.e., 1. Not satisfied, 2. Satisfied but partially, 3. Completely satisfied with the treatment.
Side-effects like koebnerization, irritant contact dermatitis, folliculitis and cutaneous atrophy will be noted in both the treatment groups.
- Conditions
- Vitiligo
- Being tested
- Microneedling with 5-fluorouracil, Topical application of 0.05% Clobetasol propionate
- Keywords
- Vitiligo, Limited, Microneedling, 5-FU
- 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 5-fluorouracilDrug
Micro-needling will be done, 2 passes will be made on the affected patch of vitiligo with 5 FU. Not more than 0.5 ml 5FU will be used during each session. Session will be repeated 2 weekly for 6 months.
Topical application of 0.05% Clobetasol propionateDrug
Topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with topical 5-fluorouracil | Experimental | Not described Receives: Drug: Microneedling with 5-fluorouracil |
| Clobetasol propionate 0.05% | Active comparator | Not described Receives: Drug: Topical application of 0.05% Clobetasol propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-pigmentation of vitiligo patches of patients treated with 5FU with micro-needling versus potent topical steroids at week 12 as assessed by decrease in VASI (Vitiligo Area Scoring Index) scores, ranging from score 0 to 100.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start8 Aug 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Khan, Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398807
- Sponsor's protocol ID
- 1516/EC/14/2025
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2025
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combining Micro Needling With 5 Fluorouracil Versus Potent Topical Steroids; in Treating Limited Vitiligo- Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07398807
- Acronym / sponsor ID
- 1516/EC/14/2025
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Limited, Microneedling, 5-FU
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur PakistanUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 10 Feb 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 how well 5 fluorouracil (5FU) with micro-needling works to treat limited vitiligo as compared to strong steroid applied on skin. It will also learn about the safety of both these treatments. The main questions it aims to answer are:
- How well does 5FU with microneedling work to treat vitiligo by returning pigmentation in vitiligo patches as compared to steroid?
- What is participant's satisfaction when treated with 5FU with microneedling as compared to steroid?
- What skin problems do participants have when treated with FU with microneedling and steroid?
Researchers will compare 5FU with microneedling to steroid application to see how well both work to return pigment in vitiligo patches.
Participants will be divided into two groups. For Group A, 5 FU will be rubbed and absorbed on the vitiligo patch after micro-needling every 2 weeks.
For group B, topical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches for 12 weeks.
Vitiligo patches will be assessed at the start of trial and then after 12 weeks of treatment.
Detailed description
The rationale of this study is to find a cost-effective treatment regime of 5 fluorouracil for limited stable vitiligo. We aim to compare how effective is the combination of micro-needling with 5 Fluorouracil versus topical potent steroids in the cases of stable, limited vitiligo (< 10% body surface area -BSA).
40 patients with limited vitiligo consulting the dermatologist in the hospital OPD will be included in the trial after application of the mentioned inclusion and exclusion criteria. After informed consent, a dermatologist will explain the required details of the procedure to the patients and give them their required treatment plan. They will be randomized into two groups by lottery method.
Demographic data like age, gender, location and number of vitiligo patches will be recorded along with baseline photograph and measurement of the vitiligo patches by VASI score.
In first group i.e., Group A, a topical eutectic mixture of local anesthetic in cream formulation (EMLA) will be applied over the patient's lesions for 30- 45 minutes. Lesion will be cleaned by pyodine iodine applied for at least 5 minutes. Micro-needling will be done by dr. Pen Ultima A6 with 42 needle cartridges (single usage) with 3mm depth and 2 passes will be made on the effected patch of vitiligo. Sterile gauze will be pressed on the lesion for 2 minutes to stop bleeding. Afterwards depth will be decreased to 1.5mm and 5 FU will be rubbed on the lesion before this step. Aim would be to facilitate percutaneous absorption of the drug with micro-needling. Micro-needling device will be held at 90-degree angle and will be glided up and down, followed by side to side and then diagonal sections with light pressure to avoid dragging. Few drops of 5 FU will be rubbed and absorbed again on the vitiligo patch after micro-needling. Not more than 0.5 ml 5FU will be used during each session. Lesions will be covered by a sterile dressing after the procedure. It will be removed after 12 hours. Patient will be instructed to avoid bathing for 24 hours after the procedure. 6 sessions will be done at 2 weeks interval.
Group B will be advised topical 0.05% clobetasol propionate ointment twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams. The application should be continued for 12 weeks.
A blinded independent medical observer will perform clinical assessment at the end of 12 weeks treatment period using the VASI score and using the following grading scale for all 40 patients: 1, < 25% minimal regain of pigment in the lesion; 2, 26-50% mild regain of pigment in the lesion; 3, 51-75% moderate regain of pigment in the lesion; 4, >75% excellent regain of pigment in the lesion.
Patient satisfaction will also be assessed by grading scale i.e., 1. Not satisfied, 2. Satisfied but partially, 3. Completely satisfied with the treatment.
Side-effects like koebnerization, irritant contact dermatitis, folliculitis and cutaneous atrophy will be noted in both the treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling with topical 5-fluorouracil | Experimental | Drug: Microneedling with 5-fluorouracil |
| Clobetasol propionate 0.05% | Active comparator | Drug: Topical application of 0.05% Clobetasol propionate |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients willing to participate in the study
- Patients of age group of 05 -70 years.
- Vitiligo involving less than or equal to 10% body surface area.
Key exclusion criteria (7 listed)
- Patients using or have used other treatments for vitiligo
- Pregnant women or lactating women
- Patients with unstable vitiligo
- Patients on immunosuppressant medications due to other diseases
- Patients having anemia, immunosuppression, bleeding disorder, taking anticoagulants or anti-platelet drugs or having epilepsy
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 5-fluorouracilMicro-needling will be done, 2 passes will be made on the affected patch of vitiligo with 5 FU. Not more than 0.5 ml 5FU will be used during each session. Session will be repeated 2 weekly for 6 months. | Drug | Microneedling with topical 5-fluorouracil |
| Topical application of 0.05% Clobetasol propionateTopical 0.05% clobetasol propionate ointment will be applied twice a day on the vitiligo patches.1 finger-tip unit (FTU) will be used for 2% BSA i.e., 0.5 grams. | Drug | Clobetasol propionate 0.05% |
Primary outcome
Re-pigmentation of vitiligo patches of patients treated with 5FU with micro-needling versus potent topical steroids at week 12 as assessed by decrease in VASI (Vitiligo Area Scoring Index) scores, ranging from score 0 to 100.
Time frame: From enrollment to the end of treatment at 6 months
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 17 Feb 2026.
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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.
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 Microneedling with 5-fluorouracil and Topical application of 0.05% Clobetasol propionate in people with Vitiligo, run by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-pigmentation of vitiligo patches of patients treated with 5FU with micro-needling versus potent topical steroids at week 12 as assessed by decrease in VASI (Vitiligo Area Scoring Index) scores, ranging from score 0 to 100. (time frame: From enrollment to the end of treatment at 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 17 Feb 2026.