Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

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.

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.

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.

Topical cream, generic formulation of the brand product.

Generic Fluorouracil Cream

Carac® (Fluorouracil) Cream

Topical cream, placebo. Has no active ingredient.

Vehicle Cream

Study Director

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.

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.

Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses

Percentage of participants with treatment success (complete clearance) at Week 6 (4 weeks after completion of 2 weeks of treatment). Complete clearance was defined as having no (zero) clinically visible actinic keratoses (AK) lesions in the treatment area at the Week 6/End Of Study visit. All AK lesions (baseline and new lesions) independent of size within the treatment area were treated and included in the efficacy lesion count.

Actavis Inc.

Adverse events were collected from participants who were randomized and received the study drug.

Participants applied 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 was no longer visible. Participants were 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 was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.

Participants applied 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 was no longer visible. Participants were 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 was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.

Carac (Fluorouracil) Cream

Participants applied 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 was no longer visible. Participants were 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 was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Participants who received the study drug (Safety Population).

Director, CE Studies

Participants in mlTT population who met inclusion/exclusion criteria, applied 75%-125% applications of study drug, did not miss applications for more than 3 consecutive days, no evidence of dosing noncompliance, and completed evaluation at Week 6 within ±4 days with no protocol violations that would affect treatment evaluation (PP Population).

Percentage of Participants With Treatment Success (Complete Clearance) at Week 6

Participants applied up to 1 gram of generic fluorouracil 0.5% topical cream once daily for 2 weeks (wks) as a thin film to the skin of the treatment area and rub until the cream was no longer visible. Participants were 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 was to have been left on the skin for approximately 8 hours and then removed by washing the area with mild soap and water. Treatment should have continued for the full treatment course even if the actinic keratoses lesions appeared to be gone.

Spots Global Cancer Trial Database for Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

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