Efficacy of intra lesional injection of 5-flourouracil on keloid scar: A prospective open clinical trial

Abstract

Background and objectives: The management of keloids stayed unsatisfactory. Intralesional 5-fluorouracil has not been broadly and intensively studied as a monotherapy in the treatment of keloids worldwide. So, the aim of this study was to evaluate the efficacy and safety of intralesional injection of 5-flourouracil in patients with keloids. Methods: In this prospective clinical trial study, a total of 20 patients aged >18 years at Shahid Jabar Dermatological Teaching Center, Sulaimaniyah, Iraq, from January 2022 to August 2022 were enrolled. Patients were treated at 1-week interval with intralesional injection of 5-flurouracil (50 mg/mL) at maximum of 6 sessions. Average injection volume was 0.2 mL/cm2. All patients were followed up for 6 months. Results: Most of the patients were aged <50 years (90%) with no family history of keloid (75%). Additionally, 45% of patients had keloid in the trunk region with a size of ?10 cm2 (65%). Most patients (80%) had the disease for ?5 years that caused by inflammation (55%), especially skin type IV (65%). After 6 sessions of treatment, 70% of patients showed moderate improvement, while 30% of patients showed minimum improvement. The main adverse effects after 6 sessions of treatment were hyperpigmentation in 3 patients, bullae in 2 patients, and tissue sloughing only in 1 patient. A significant correlation was found between the patient’s response and age/keloid location. Moreover, mean Redness, Elevation, Hardness, Itching, and Tenderness score after treatment was significantly lower than before treatment (p<0.001). Conclusions: Our results concluded that 5-flurouracil is a safe and effective therapy for the treatment of keloids.