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CompletedNCT01396811Updated Aug 28, 2013

Topical Antifungal Treatment for Tinea Pedis

A Phase 3 interventional study of 33525 and Placebo in Tinea Pedis, sponsored by Medicis Global Service Corporation. Completed at 11 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2013-08-28.

Sponsored by Medicis Global Service Corporation (part of Bausch Health Companies Inc.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
322
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.

02

Conditions studied

  • Tinea Pedis

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Keywords

  • Tinea Pedis
  • Antifungal
03

In context

Tinea Pedis

73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.

This study's enrollment of 322 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.

Browse Tinea Pedis studies →

Lead sponsor

Medicis Global Service Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.

First submitted before Medicis Global Service Corporation became part of Bausch Health Companies Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion criteria

Exclusion Criteria:

  • Pregnancy and allergies
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
322 participants (actual)

Study arms

  • Experimental
    Active

    Product 33525

    Drug: 33525

  • Placebo comparator
    Placebo

    Product 33525 Placebo

    Drug: Placebo

Interventions

  • Drug33525

    Daily for 14 days

  • DrugPlacebo

    Daily for 14 days

06

What researchers measure

Primary outcomes

  1. Proportion of patients achieving complete clearance

    Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

    Time frame: Day 42

Secondary outcomes

  1. Proportion of patients achieving effective treatment

    Clinical Cure and Mycologic Cure

    Time frame: Day 42

07

Study locations

11 sites
  • Miami, Florida, United States
  • Miramar, Florida, United States
  • Augusta, Georgia, United States
  • Evansville, Indiana, United States
  • Warren, Michigan, United States
  • Hackensack, New Jersey, United States
  • High Point, North Carolina, United States
  • Cinncinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Belize City, Belize
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01396811
Responsible party
Sponsor
First posted
Jul 19, 2011
Start date
Jul 2011
Primary completion
Jan 2012
Completion
Mar 2012
Last update
Aug 28, 2013

Study contacts

Ron Staugaard
study director · Medicis Pharmaceutical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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