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

PHASE1CompletedINTERVENTIONAL

Enrollment

435

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

July 31, 2013

Study Completion Date

October 31, 2013

Conditions

Actinic Keratosis

Interventions

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.

All Listed Sponsors

lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY

NCT01742663 - A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis | Biotech Hunter | Biotech Hunter