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

ConditionKeloids
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCombined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cryotherapy will be done followed by intralesional injection of 5-fluorouracil
  • Intralesional 5-fluorouracil

Treatment groups

88 Participants
are divided into 2 treatment groups