Comparing Safety and Effectiveness of Intralesional 5-Fluorouracil With and Without Cryotherapy for Treating Keloid Scars

What this Trial Is About

This research aims to compare two treatments for keloid scars cryotherapy followed by intralesional 5 fluorouracil 5FU and intralesional 5 fluorouracil alone. It will assess how well cryotherapy combined with 5FU works compared to 5FU alone, participant satisfaction with these treatments, and any skin problems that may occur. The study is an early phase 1 randomized controlled trial involving 88 patients aged 18 to 50 years with symptomatic keloids. Participants will be randomly assigned to one of two groups. Group A will receive cryotherapy at the keloid site using liquid nitrogen spray with freeze-thaw cycles, followed 30 minutes later by an injection of 5FU mixed with triamcinolone acetonide. Group B will receive only the intralesional injection of 5FU combined with triamcinolone acetonide. Both treatments will be given every three weeks for a total of four sessions. Local anesthesia and oral painkillers will be used to manage pain. During the 12-week treatment period, researchers will assess keloid severity using the DKS score and record patient satisfaction with a seven-point improvement scale. Side effects such as severe pain, blistering, infection, and eschar formation will be monitored from the first hour after each injection. A blinded dermatologist will document side effects, and an independent observer will evaluate treatment outcomes. The studys total participation spans the 12 weeks of treatment with regular assessments.

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