5‑fluorouracil injections with or without cryotherapy for keloids
Official title: A Randomized Controlled Trial Comparing The Effectiveness And Safety Of iIntralesional 5 Flourouracil Monotherapy Verses 5 Flourouracil Combined With Cryotherapy; In The Treatment Of Keloid Scars
Run by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · NCT07531056 · Data updated 2026-11-12
This trial tests whether adding cryotherapy to intralesional 5‑fluorouracil works better than 5‑fluorouracil alone for adults (18–50) with symptomatic keloids.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan Academic / other |
| Locations | 1 site (Chak Eighty-seven -Twelve Left) |
| Status | Recruiting |
| Started | December 22, 2025 |
| Main results expected | September 20, 2026 |
| Study ends | September 20, 2026 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT07531056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–50 with symptomatic keloids who can attend CMH Bahawalpur visits, are willing to consent, and have no contraindications to 5‑fluorouracil are the ideal candidates.
✕Probably not a fit
People outside the age range, pregnant or lactating women, or those with significant comorbidities, myelosuppression, immunosuppression, warfarin use, or known 5‑FU allergy are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial will enroll 88 adults with symptomatic keloids and randomly assign them to two groups. One group will receive cryotherapy at the lesion followed by intralesional 5‑fluorouracil, and the other group will receive intralesional 5‑fluorouracil alone. Investigators will record baseline photographs, demographic and clinical data, and a scar severity (DSS) score, then compare lesion response, patient satisfaction, and skin adverse effects over follow-up visits. Safety screening excludes pregnancy, lactation, significant liver/renal/cardiac disease, myelosuppression, immunosuppression, warfarin use, and known 5‑FU hypersensitivity.
Why it matters
Potential benefit: If successful, the combination could provide a low-cost approach that reduces keloid size and symptoms more effectively than injections alone.
How similar studies have gone: Smaller trials and case series have reported improved keloid response when combining cryotherapy with intralesional 5‑FU, but larger randomized confirmation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients willing to participate in the study * Patients of age group of 18 -50 years. * Patients having symptomatic keloids i.e., having pain, pruritus, restriction of movement, scar tension or disfigurement. Exclusion Criteria :• Pregnant women or lactating women * Patients with history of hepatic, renal, cardiac diseases or chronic diarrhea. * Patients on immunosuppressant medications due to other diseases * Patients having myelosuppression checked by CBC. * Patient taking warfarin. * Patients with history of hypersensitivity to 5FU.
Where it's running
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CMH Bahawalpur
Chak Eighty-seven -Twelve Left, Pakistan Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.