Trials / Completed
CompletedNCT02611804
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 492 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald scalp.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diclofenac sodium | |
| DRUG | Diclofenac sodium | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2015-11-23
- Last updated
- 2017-05-05
Locations
30 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02611804. Inclusion in this directory is not an endorsement.