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RECRUITING
NCT07531056
EARLY_PHASE1

COMPARISON OF EFFECTIVENESS OF INTRALESIONAL INJECTIONS OF 5-FLOUROURACIL ALONE VERSES ITS COMBINATION WITH CRYOTHERAPY IN THE TREATMENT OF KELOIDS

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-12-22

Completion Date

2026-09-20

Last Updated

2026-04-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

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

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.

DRUG

Intralesional 5-fluorouracil

intralesional 5-FU will be given in phases. sessions will be repeated after every 3 weeks for 6 months

Locations (1)

CMH Bahawalpur

Chak Four Hundred Fifty-four, Pakistan