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NCT00835510 · ClinicalTrials.gov registry record · Phase 1
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
A Phase 1 study, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 1
- Development phase
- 548
- Enrollment target
NCT00835510 is a Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 548 participants.
The verdict
NCT00835510, a Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 548 participants
- Enrollment target
Study Summary
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Interventions
- DRUG Butenafine cream 1% manufactured by Taro
- DRUG Lotrimin Ultra (butenafine) 1%
- DRUG Butenafine Vehicle manufactured by Taro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 548 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00835510
The ClinicalTrials.gov registry entry for NCT00835510 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Butenafine cream 1% manufactured by Taro is the first listed.
NCT00835510 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00835510 about?
NCT00835510 is a clinical study titled "Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis". To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (v...
What is the current status of trial NCT00835510?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 548 participants. The study started on 2008-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00835510?
The interventions under investigation include: Butenafine cream 1% manufactured by Taro (DRUG), Lotrimin Ultra (butenafine) 1% (DRUG), Butenafine Vehicle manufactured by Taro (DRUG).
Who is sponsoring clinical trial NCT00835510?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
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