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

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.

Timeline

Start

2015-02-27

Primary completion

2015-09-17

Completion

2015-09-17

Outcome

Met primary endpoint

registry analysis (superiority test); Generic Fluorouracil Cream vs Vehicle Cream; p <0.0001; Fisher Exact NCT02616601 ↗

Drugs

Indications