NCT07531056 Comparison Of Effectiveness Of Intralesional Injectioms Of 5 Flourouracil Alone Verses Its Cpmbination With Cryotherapy In The Treatment Of Keloids
| NCT ID | NCT07531056 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan |
| Condition | Keloids |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-09-20 |
Trial Parameters
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Brief Summary
The goal of this clinical trial is to learn how well intralesional 5 fluorouracil with cryotherapy works to treat keloids as compared to intralesional 5 fluorouracil alone on keloids. It will also learn about the safety of both these treatments. The main questions it aims to answer are: * What well does cryotherapy followed by intralesional 5 fluorouracil (5FU) work to treat keloids as compared to 5 fluorouracil (5FU) alone? * What is participant's satisfaction when treated with cryotherapy followed by intralesional 5 fluorouracil (5FU) as compared to 5 fluorouracil (5FU) alone? * What skin problems do participants have when treated with cryotherapy followed by intralesional 5 fluorouracil (5FU) and 5 fluorouracil (5FU) alone? Researchers will compare cryotherapy followed by intralesional 5 fluorouracil (5FU) with 5 fluorouracil (5FU) alone to see how well both work. Participants will be divided into two groups: For Group A: Cryotherapy will be done at lesion site followed by intralesional 5FU every 3 weekly. For Group B: Intralesional 5FU will be given at lesion site every 3 weekly. Keloids will be assessed at the start of trial and then after 12 weeks of treatment.
Eligibility 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.