Efficacy of 0.5% 5-Fluorouracil Cream and Absence of Undesirable Secondary Effects in the Treatment of Grade III Actinic Keratoses in the Presence of 5% Dobesilate

Background: 5-Fluorouracil (5-FU) has been a standardized topical treatment for actinic keratosis (AK) lesions, however to treat deep and hyperkeratotic AK a long treatment time is often required. Furthermore, in grade III variant AK, 5-FU normally shows a clear inefficacy. In addition, the drug can cause important inflammatory reactions and scarring. Previous studies performed at our institution reveal that topical potassium dobesilate cream counteracts efficiently skin inflammation. Objective: We propose a combinatorial application of fluorouracil and potassium dobesilate to increase the short-term clearance of grade III AK lesions without cutaneous secondary reactions. Methods: A cream containing 5-FU 0.5% and potassium dobesilate 5% was applied twice daily for 4 to 8 weeks to grade III variant of AK lesions located in the scalp and in the face. The cream was prepared at the Pharmacy Service of the Hospital Universitario Ramón y Cajal in Madrid, Spain. Formulation didn’t contain any keratolytic agent. The lesions were evaluated at an initial baseline visit and every week during 8 weeks. For follow-up observation, patients were also clinically evaluated six months after treatment. Results: There was a 100% clearance rate (12/12) of AK lesions treated with 0.5% fluorouracil and 5% potassium dobesilate cream. Moreover, the cosmetic outcome was excellent