NCT01742663

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

A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Gel 3%	Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
DRUG	Solaraze® (diclofenac sodium) Gel 3%	Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)applied twice daily for 60 days.
DRUG	Vehicle Topical Gel	Vehicle Topical Gel (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2013-10-01
• First posted: 2012-12-05
• Last updated: 2014-01-22