Trials / Completed
CompletedNCT02132260
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 890 (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 efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naftifine Hydrochloride Cream 2% | Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks |
| DRUG | Naftin® (Naftifine Hydrochloride) Cream 2% | Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks. |
| DRUG | Placebo Topical Cream | Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks. |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2014-02-01
- Completion
- 2014-03-01
- First posted
- 2014-05-07
- Last updated
- 2017-05-09
Source: ClinicalTrials.gov record NCT02132260. Inclusion in this directory is not an endorsement.