At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 476 enrolled
Drug / intervention
Diclofenac sodium +1 moredrug
Likely dose
Diclofenac sodium 0.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze ® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis
In Brief
A Phase 3 clinical trial evaluating Diclofenac sodium and Placebo for Actinic Keratosis. Completed, enrolled 476 participants across 31 sites.
Detailed Summary
To compare the relative efficacy and safety of the test formulation diclofenac sodium gel 3% (Actavis) to the marketed formulation Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms) in the treatment of the actinic keratosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
Primary CompletionSep 2013
First PostedOct 2013
TodayJul 2026
First PostedOct 16, 2013
Enrollment StartMar 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.7 years ago
Interventions
Diclofenac sodiumdrug
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
Placeboother
Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.