Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen’s disease: a multicenter randomized controlled trial

INTERVENTION: Trade Name: Efudix Pharmaceutical Form: Cream Trade Name: Metvix 160 mg/g crème Pharmaceutical Form: Cream CONDITION: Bowens's disease Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: ; Secondary Objective: To compare the effectiveness of 5‐fluorouracil cream (5FU) with that of photodynamic therapy (PDT) in Bowen’s Disease (BD). ; To examine if 5‐fluorouracil cream (5FU) and photodynamic therapy (PDT) result in greater patient satisfaction and/or cosmetic result compared to surgical excision (SE) in Bowen’s Disease (BD).; Main Objective: To determine the (cost)effectiveness of 5‐fluorouracil cream (5FU) and photodynamic therapy (PDT), compared to surgical excision (SE) in Bowen’s Disease (BD). Primary end point(s): Proportion of patients with sustained clearance. Timepoint(s) of evaluation of this end point: At 3 and 12 months and 2‐years and 5‐years post treatment. SECONDARY OUTCOME: Secondary end point(s): Cost‐effectiveness, side effects, cosmetic outcome, patient satisfaction, patient preference and compliance. Timepoint(s) of evaluation of this end point: At 3 and 12 months INCLUSION CRITERIA: ‐Adults = 18 years ‐Histologically proven primary Bowen’s disease ‐Lesions = 4mm and = 40mm in diameter ‐Fitzpatrick skin type I‐IV ‐Female in child bearing potential should be using contraceptive measures, during and till 3 months post‐treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 118