NCT07531056

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for early_phase_1

Timeline
5mo left

Started Dec 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 22, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 1, 2026

Last Update Submit

April 11, 2026

Conditions

Keloids

Keywords

KeloidsIntralesional injectioms5-FU

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Cryotherapy followed by intralesional injection of 5-FU

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

Intralesional injection of 5-FU

ACTIVE COMPARATOR
Drug: Intralesional 5-fluorouracil

Interventions

Intralesional 5-fluorouracilDRUG

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

Intralesional injection of 5-FU
Cryotherapy will be done followed by intralesional injection of 5-fluorouracilDRUG

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.

Cryotherapy followed by intralesional injection of 5-FU

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • :• 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Bahawalpur

Chak Four Hundred Fifty-four, Pakistan

RECRUITING

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 15, 2026

Study Start

December 22, 2025

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

PA(1)