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

April 21, 2026 updated by: Sara Khan, Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

A Randomized Controlled Trial Comparing The Effectiveness And Safety Of iIntralesional 5 Flourouracil Monotherapy Verses 5 Flourouracil Combined With Cryotherapy; In The Treatment Of Keloid Scars

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The rationale of this study is to find cost-effective treatment regime of cryotherapy with intralesional 5 fluorouracil for keloids. Investigator aim to compare how effective is the combination of cryotherapy followed by intralesional 5 fluorouracil (5FU) as compared to 5 fluorouracil (5FU) alone in the treatment of keloids.

88 patients with keloids consulting the dermatologist in the hospital OPD will be included in the trial after application of the mentioned inclusion and exclusion criteria. After informed consent, a dermatologist will explain the required details of the procedure to the patients and give them their required treatment plan. Participanys will be randomized into two groups by lottery method. Demographic data like age, gender, location, duration, number of keloids, Fitzpatrick skin type, family history of keloids, keloid symptoms (pain, itching or disfigurement), previous treatments (topical steroids, topical silicone sheet or cream, cryotherapy, surgical excision, intralesional steroids or none) will be recorded along with the baseline photograph and rating of severity score based on DSS score. For Group A, Cryotherapy will be done by a spray mini-cryogun ( Brymill B800 Cry-Ac 3 dispenser) using liquid nitrogen targeted at the lesion from the distance of 1 cm and freeze thaw cycles of 30 seconds will be repeated till the lesion freezes to the level of its contact with skin. With larger lesions 2cm2 area will be targeted in a stepwise manner to ensure homogenous cryotherapy of the entire lesion. Local anaesthesia will be given before the cryotherapy with bupivacaine injection, as it relives pain up to 72 hours. 30 minutes after the cryotherapy session intralesional injection of 5 fluorouracil 50mg/ml 0.75ml mixed with 0.25ml triamcinolone acetonide 10mg/ml for every 2cm2 of keloid using a 30-gauge needle with a 3cc syringe. Not to exceed 150 mg/ml in a single session. The injection will be pushed gently into the lesion to the point of inducing swelling and blanching of lesion. The lesion shall be bandaged for 01 hour after the injection.

Group B will be advised local anaesthesia with bupivacaine followed intralesional injection of 5 fluorouracil 50mg/ml 0.75ml mixed with 0.25ml triamcinolone acetonide 10mg/ml for every 2cm2 of keloid. Not to exceed 150 mg in a single session. Oral pain killer will be prescribed for 3 days usage after injection in both treatment groups. Treatment in both groups will be repeated every 3 weeks for 4 sessions in total. If there will be large necrotic area after the previous session, it will be allowed to heal before the next session.

A blinded independent medical observer will perform clinical assessment at the end of 12 weeks treatment period using the DKS score for all 88 patients.

Participant satisfaction will be checked by Patient Global Impression-improvement scale, which is a seven-point scale used by patient to report the overall improvement in their disease with treatment as 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse and 7: very much worse. 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. A blinded dermatologist from our department will keep record of the side-effects.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

:• 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy followed by intralesional injection of 5-FU
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.
Active Comparator: Intralesional injection of 5-FU
Drug: Intralesional 5-fluorouracil
intralesional 5-FU will be given in phases. sessions will be repeated after every 3 weeks for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: From enrollment to the end of treatment at 12 weeks
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2025

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1587/EC/14/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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