Comparing Efficacy and Safety of Potassium Hydroxide 5% Solution With 5-Fluorouracil Cream in Patients With Actinic Keratoses: A Randomized Controlled Trial Publisher Pubmed



Salehi Farid A¹ ; Niknam S² ; Gholami K³ ; Tavakolpour S^{1, 4} ; Teimourpour A⁵ ; Daneshpazhooh M¹ ; Nili A¹ ; Azizpour A¹ ; Nasimi M¹ ; Mahmoudi H¹
Source: Journal of Dermatological Treatment Published:2022

Abstract

Background: Actinic keratosis (AK) is a pre-cancerous skin lesion, associated with development of squamous cell carcinoma. Current treatment options are limited. Objectives: To compare the efficacy and safety of topical 5-fluorouracil cream (5-FU) and potassium hydroxide 5% (KOH) in the treatment of AK. Methods: Eighteen patients with AK applied KOH solution or 5-FU on each side of their scalp/face, randomly. The efficacy and safety of these treatments were compared. Results: Thirteen (118 lesions) and ten (83 lesions) patients were successfully followed for one and three months, respectively. After one month, KOH showed a better clinical response (81% vs. 58%; p-value = 0.007) and dermoscopic response (KOH, 65% vs. 5-FU, 46%; p-value = 0.04); while no differences were noted after three months (clinical response, 83% vs.70%, p-value = 0.1; dermoscopic response, 76% vs. 59%, p-value = 0.1). No significant differences in the recurrence rate of the lesion between the two groups were noted at the end of the third month (p-value = 0.5). Regarding the safety of the treatments, the risk of developing erythema, scaling, sand swelling was higher in 5-FU group (p-value < 0.0001, for all), while more patients in KOH group had erosion and ulcer (p-value < 0.001 for both). KOH was up to 96% less expensive than 5-FU. Limitations: Low number of patients and short-term follow-up limited the analysis. Conclusion: KOH solution offers a faster and less expensive resolution of AK lesions than does 5-FU. Clinical Trial Code (IRCT.ir): IRCT20180909040978N1. © 2020 Taylor & Francis Group, LLC.