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

NCT07526168 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Keloid

Interventions

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

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-08-01

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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 NCT07526168 on ClinicalTrials.gov