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Intralesional Cryosurgery Alone Versus Combined With 5-FU and Triamcinolone for Keloids
Sponsor: Assiut University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-07-01
Completion Date
2027-08-01
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
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
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.