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.
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.
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.
Parallel
Cryotherapy will be done followed by intralesional injection of 5-fluorouracil
DrugCryotherapy 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-fluorouracil
Drugintralesional 5-FU will be given in phases. sessions will be repeated after every 3 weeks for 6 months
Side-effects like severe pain, blistering, infection and eschar formation will be noted in both groups within the 12 weeks treatment period starting from the 1st hour post injection
Click on the lead sponsor to view all of their trials.
