Comparison Of Effectiveness Of Intralesional Injectioms Of 5 Flourouracil Alone Verses Its Cpmbination With Cryotherapy In The Treatment Of Keloids
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
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan
88 participants
Dec 22, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- :• 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.
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Interventions
Cryotherapy will be done followed by intralesional injection of 5-FU diluted in steroid, this will be done in phases. Not more than 150mg 5-FU will be used during each session. Session will be repeated after every 3 week for 6 months.
intralesional 5-FU will be given in phases. sessions will be repeated after every 3 weeks for 6 months
Locations(1)
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NCT07531056