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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: Completed Phase 1 study, sponsored by Sun Pharmaceutical Industries.
NCT00835510 is a Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 548 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (813% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was \<2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium
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 |
What the finished NCT00835510 record still lists
NCT00835510 is an interventional study that assigns participants to a tested intervention. The registered 548 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (813% higher).
The record links to 0 conditions, and to 3 interventions - of which Butenafine cream 1% manufactured by Taro is the first listed.
NCT00835510 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835510's enrollment target sits among peer trials
548 35th of 2000 higher than 1,966 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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