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NCT00691184 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis

A Phase 1 study of Onychomycosis/Onycholysis and Tinea Pedis, sponsored by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.).

Completed
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT00691184: Completed Phase 1 study of Onychomycosis/Onycholysis and Tinea Pedis, sponsored by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.).

NCT00691184 is a Phase 1 study of Onychomycosis/Onycholysis and Tinea Pedis that has completed, run by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.). The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00691184, a Phase 1 study of Onychomycosis/Onycholysis and Tinea Pedis, has completed, sponsored by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.).

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study Summary

In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

Interventions

  • DRUG Placebo
  • DRUG Terbinafine Hydrochloride
  • DRUG Terbinafine

Study Locations (1)

New Jersey

  • TKL Research Inc. - Paramus

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2005-02
Est. Completion 2005-12
Phase Phase 1

What the finished NCT00691184 record still lists

NCT00691184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 1 condition, with Onychomycosis/Onycholysis and Tinea Pedis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00691184 reports a single indexed study location in New Jersey.

Frequently Asked Questions

What is clinical trial NCT00691184 about?

NCT00691184 is a clinical study titled "Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis". In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

What is the current status of trial NCT00691184?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2005-02. Estimated completion is 2005-12.

What conditions does trial NCT00691184 study?

This clinical trial studies the following conditions: Onychomycosis/Onycholysis and Tinea Pedis.

What interventions are being tested in trial NCT00691184?

The interventions under investigation include: Placebo (DRUG), Terbinafine Hydrochloride (DRUG), Terbinafine (DRUG).

Who is sponsoring clinical trial NCT00691184?

This trial is sponsored by NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.), which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00691184 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00691184's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 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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Source: ClinicalTrials.gov NCT00691184, the US trial registry maintained by the National Library of Medicine. NCT00691184 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.