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NCT04203342 · ClinicalTrials.gov registry record · Phase 3
A Therapeutic Equivalence Study of Ketoconazole Cream 2%
A Phase 3 study of Tinea Pedis, sponsored by Douglas Pharmaceuticals America.
- Completed
- Registry status
- Phase 3
- Development phase
- 682
- Enrollment target
- 3
- Study locations
NCT04203342: Completed Phase 3 study of Tinea Pedis, sponsored by Douglas Pharmaceuticals America.
NCT04203342 is a Phase 3 study of Tinea Pedis that has completed, run by Douglas Pharmaceuticals America. The registered enrollment target is 682 participants, above the 251-participant average among 9 other Tinea Pedis trials with a reported enrollment target (172% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04203342, a Phase 3 study of Tinea Pedis, has completed, sponsored by Douglas Pharmaceuticals America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 682 participants
- Enrollment target
- 3
- Study locations
Study Summary
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
Primary Outcome
The proportion of subjects in each treatment group with a Therapeutic Cure of tinea pedis at the test-of-cure visit conducted 2 weeks after the end of treatment (Day 56 +/- 4). Therapeutic cure is defined as having both a clinical and mycological cure of tinea pedis.
Conditions Studied
Interventions
- DRUG Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)
- DRUG Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)
- DRUG Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)
Study Locations (3)
Florida
- Moore Clinical Research - Brandon
- Moore Clinical Reseach - Tampa
Other
- FXM Research International - Belize City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2020-07-13 |
| Phase | Phase 3 |
What the finished NCT04203342 record still lists
NCT04203342 is an interventional study that assigns participants to a tested intervention. The registered 682 participants enrollment target is mid-sized for trials with a published cap, above the 251-participant average among 9 other Tinea Pedis trials with a reported enrollment target (172% higher).
The record links to 1 condition, with Tinea Pedis appearing as the primary indexed condition, and to 3 interventions - of which Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) is the first listed.
NCT04203342 reports a single indexed study location in Florida, Other.
Frequently Asked Questions
What is clinical trial NCT04203342 about?
NCT04203342 is a clinical study titled "A Therapeutic Equivalence Study of Ketoconazole Cream 2%". Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
What is the current status of trial NCT04203342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 682 participants. The study started on 2019-12-11. Estimated completion is 2020-07-13.
What conditions does trial NCT04203342 study?
This clinical trial studies the following conditions: Tinea Pedis.
What interventions are being tested in trial NCT04203342?
The interventions under investigation include: Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.) (DRUG), Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA) (DRUG), Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.) (DRUG).
Who is sponsoring clinical trial NCT04203342?
This trial is sponsored by Douglas Pharmaceuticals America, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04203342 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinea Pedis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04203342's enrollment target sits among peer trials
682 2nd of 9 the highest of 9 other Tinea Pedis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinea Pedis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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