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A Therapeutic Equivalence Study of Ketoconazole Cream 2%
NCT04203342 · View on ClinicalTrials.gov ↗
Study Summary
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04203342
The ClinicalTrials.gov registry entry for NCT04203342 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 682 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Douglas Pharmaceuticals America, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04203342 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Florida, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04203342?
This trial is sponsored by Douglas Pharmaceuticals America, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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