Trials / Completed
CompletedNCT02767947
Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Luliconazole Cream 1% | Luliconazole cream will be applied per schedule specified in the arm. |
| DRUG | Vehicle Cream | Vehicle cream will be applied per schedule specified in the arm. |
Timeline
- Start date
- 2016-02-08
- Primary completion
- 2016-06-29
- Completion
- 2016-09-22
- First posted
- 2016-05-11
- Last updated
- 2019-11-27
- Results posted
- 2019-11-27
Locations
3 sites across 2 countries: Dominican Republic, Honduras
Source: ClinicalTrials.gov record NCT02767947. Inclusion in this directory is not an endorsement.