Comparison Of Effectiveness Of Intralesional Injectioms Of 5 Flourouracil Alone Verses Its Cpmbination With Cryotherapy In The Treatment Of Keloids

Recruiting now · Early Phase 1

Conditions studied: Keloids

In brief

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.

Key facts

Study ID

NCT07531056

Run by

Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

People needed

88

Starts

2025-12-22

Expected to finish

2026-09-20

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• :• 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 is running

• CMH Bahawalpur — Chak Four Hundred Fifty-four, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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