Who is sponsoring NCT01742663?

NCT01742663 is sponsored by Sun Pharmaceutical Industries, Inc..

What condition does NCT01742663 study?

NCT01742663 studies Actinic Keratosis.

What drugs are being tested in NCT01742663?

Interventions: Diclofenac Sodium Gel 3%, Solaraze® (diclofenac sodium) Gel 3%, Vehicle Topical Gel.

What is the status of NCT01742663?

NCT01742663 is currently COMPLETED.

Last reviewed 2014-01-19 · How we verify

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.

NCT01742663 Phase 1 COMPLETED

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.

Details

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	435
Start date	2012-10
Completion	2013-10

Conditions

Actinic Keratosis

Interventions

Diclofenac Sodium Gel 3%
Solaraze® (diclofenac sodium) Gel 3%
Vehicle Topical Gel

Primary outcomes

Bioequivalence — Study day 90 (30 days after completion of 60 days of treatment)
Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.