Intralesional Cryosurgery Alone Versus Combined With 5-FU and Triamcinolone for Keloids

April 10, 2026 updated by: Hadeer Ali Abouelela, Assiut University

Efficacy and Safety of Intralesional Cryosurgery Alone and in Combination With Intralesional 5-fluorouracil/Triamcinolone Acetonide Injection for Treatment of Keloids: a Comparative Clinical Study

evaluate the efficacy and safety of intralesional cryosurgery alone compared with intralesional cryosurgery combined with intralesional 5-fluorouracil and triamcinolone acetonide in the treatment of keloids.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Keloids are abnormal scars characterized by excessive collagen deposition that extends beyond the original wound boundaries, often leading to cosmetic disfigurement, pain, pruritus, and tenderness, significantly affecting patients' quality of life . Keloid formation is influenced by genetic predisposition, skin tension, wound location, and inflammatory responses, and they are notorious for high recurrence rates, with some reports indicating recurrence in up to 50-80% of cases after treatment .

Various therapeutic modalities have been used for the management of keloids. These treatment options can be broadly classified into intralesional therapies, topical therapies, and procedural interventions.

Despite the availability of multiple treatment options, no single therapy ensures complete resolution, and recurrence remains a significant challenge in keloid management .

Intralesional corticosteroids remain the first-line therapy, reducing fibroblast proliferation, collagen synthesis, and local inflammation. Clinical studies have shown flattening of keloids in 50-70% of patients with repeated injections . Another commonly used intralesional agent is 5-fluorouracil (5-FU), an antimetabolite that inhibits fibroblast proliferation and extracellular matrix deposition, with reported improvement in 70-80% of cases . Combination therapy of corticosteroids and 5-FU has demonstrated superior efficacy compared with monotherapy.

Among procedural modalities. Intralesional (IL) cryotherapy, is a technique in which a cryogen can be applied using a cryoneedle directly into the deeper dermis of the scar to produce rapid scar freezing from the core outwards, thus all the pathological tissue will be frozen and destructed, creating a new scar without keloidal characteristics, while sparing the surface epithelium. As a monotherapy, IL cryosurgery has yielded promising clinical results in terms of volume reduction and alleviation of pain and pruritus . Marked efficacy of a single intralesional cryosurgery session has been recorded even in voluminous keloids, which is an additional major advantage compared with the repeated sessions required in classical contact cryosurgery, However, on average, no complete scar eradication is attained and scar recurrence is seen. Also, persistent hypopigmentation remains problematic in nonwhite patients . These issues raise the question whether IL cryotherapy could be used in combination with nonsurgical therapies to augment the therapeutic effect and to lower the risk of hypopigmentation.

Weshahy and Abdel Hay and Stromps et combined IL cryotherapy with adjuvant therapy with silicone sheeting and triamcinolone injections, respectively .

Eisert and Nast reported good outcomes by initially using intralesional cryosurgery, followed by injection of triamcinolone, 5-fluorouracil and hyaluronidase, suggesting that such treatment also leads to significant softening of the keloid, which would otherwise be too firm to be treated with intralesional injections

Although several studies have evaluated the effectiveness of intralesional corticosteroids, 5-fluorouracil, and cryotherapy individually, data directly comparing intralesional cryotherapy with combined intralesional corticosteroid and 5-fluorouracil therapy remain limited in the literature .

The study aims to investigate whether intralesional injection of a mixture of 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) as adjuvant therapy to intralesional cryosurgery produces superior outcomes in terms of scar improvement, recurrence reduction, and hypopigmentation control.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (≥18 years) with clinically diagnosed keloids .
  • Keloids of size 1-10 cm in greatest dimension .
  • Keloids of at least one year duration

Exclusion Criteria:

  • Females who are pregnant, planning pregnancy, or lactating .
  • Hypertrophic scars .
  • Chronic kidney or liver disease (relevant for 5-FU safety) .
  • Patients with active inflammation, infection, or ulcer at or around the keloid or Lesions suspicious for malignancy .
  • Patients who received any treatment for the same keloid in the past 12 months .
  • Immunosuppressed patients or those with chronic inflammatory diseases .

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy + Saline Injection (Placebo)
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Procedure: Intralesional Cryotherapy + Saline Injection
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Experimental: Cryotherapy + TAC/5-FU Injection
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
Procedure: Intralesional Cryotherapy + TAC/5-FU Injection
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in keloid size
Time Frame: 12 weeks
Keloid severity will be assessed using the Vancouver Scar Scale (VSS), which evaluates vascularity, pigmentation, pliability, and height. Scores range from 0 to 13, with higher scores indicating more severe scarring. Assessment will be performed by blinded observers.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Scar Assessment (PSAS)
Time Frame: up to 12 weeks
Patient-reported outcomes will be evaluated using the Patient Scar Assessment Scale (PSAS), which assesses pain, pruritus, color, stiffness, thickness, and irregularity. Scores range from 6 to 60, with higher scores indicating worse scar quality.
up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dermoscopic vascular patterns and pigmentation
Time Frame: up to 12 weeks
Dermoscopy will be used to document and evaluate changes in vascular patterns, pigmentation, and structural features of the keloid. Observations will be compared between baseline and 12 weeks to assess changes
up to 12 weeks

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Keloid-ILC-2026

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.

Clinical Trials on Keloid

Clinical Trials on Intralesional Cryotherapy + Saline Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe