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NCT01290341 · ClinicalTrials.gov registry record · Phase 3

Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

A Phase 3 study, sponsored by Merz North America.

Completed
Registry status
Phase 3
Development phase
860
Enrollment target

NCT01290341: Completed Phase 3 study, sponsored by Merz North America.

NCT01290341 is a Phase 3 study that has completed, run by Merz North America. The registered enrollment target is 860 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01290341, a Phase 3 study, has completed, sponsored by Merz North America.

COMPLETED
Registry status
Phase 3
Development phase
860 participants
Enrollment target

Study Summary

This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

Primary Outcome

The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

Interventions

  • DRUG Placebo
  • DRUG NAFT-600 (naftin 2 % gel)

Trial Details

FieldValue
Enrollment Target 860 participants
Start Date 2011-02
Est. Completion 2011-12
Phase Phase 3
Merz North America

35 total trials

What the finished NCT01290341 record still lists

NCT01290341 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01290341 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01290341 about?

NCT01290341 is a clinical study titled "Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis". This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

What is the current status of trial NCT01290341?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2011-02. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01290341?

The interventions under investigation include: Placebo (DRUG), NAFT-600 (naftin 2 % gel) (DRUG).

Who is sponsoring clinical trial NCT01290341?

This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01290341's enrollment target sits among peer trials

860 380th of 2000 higher than 1,618 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01290341, the US trial registry maintained by the National Library of Medicine. NCT01290341 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.