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

NCT07531056 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Keloids

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2026-09-20
Completion
2026-09-20

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531056 on ClinicalTrials.gov