Conditions: Actinic Keratosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 422
Healthy volunteers: yes

Brief summary:
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.

Detailed description:
This is a multicenter, double-blind, vehicle-controlled, parallel group comparison study of a generic fluorouracil cream, 0.5% and Carac (fluorouracil) Cream, 0.5% in participants with actinic keratoses on the full face or balding scalp.

Arms:
arm 1: Participants are to apply up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone. arm 2: Participants are to apply up to 1 gram of Carac (fluorouracil) 0.5% topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone. arm 3: Participants are to apply up to 1 gram of vehicle topical cream once daily for 2 weeks as a thin film to the skin of the treatment area and rub until the cream is no longer visible. Participants will be instructed to apply the study drug 10 minutes after thoroughly washing, rinsing, and drying the entire treatment area and 1 to 2 hours before bedtime. Study drug should be left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should be continued for the full treatment course even if the actinic keratoses lesions appear to be gone.

Interventions: intervention 1: Generic Fluorouracil Cream intervention 2: Carac® (Fluorouracil) Cream intervention 3: Vehicle Cream
Intervention descriptions: intervention 1: Topical cream, generic formulation of the brand product. intervention 2: Topical cream, brand product. intervention 3: Topical cream, placebo. Has no active ingredient.

Protocol document: