An Early Phase 1 interventional study of Microneedling with 5-fluorouracil and Topical application of 0.05% Clobetasol propionate in Vitiligo, sponsored by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · Early Phase 1, Interventional, and Treatment
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:
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.
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Microneedling with 5-fluorouracil
Drug: Topical application of 0.05% Clobetasol propionate
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 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.
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
Started Aug 2025 (actual). Primary completion is estimated for Feb 2026, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan