A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis

Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Taro Pharmaceuticals Inc.) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of actinic keratosis. Both the test and reference formulations will also be compared to a placebo formulation to test for superiority.

Timeline

Start

2012-10

Primary completion

2013-07

Completion

2013-10

Drugs

Indications