NCT01396811

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

6 months

First QC Date

July 15, 2011

Last Update Submit

August 20, 2013

Conditions

Tinea Pedis

Keywords

Tinea PedisAntifungal

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving complete clearance

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

    Day 42

Secondary Outcomes (1)

  • Proportion of patients achieving effective treatment

    Day 42

Study Arms (2)

Active

EXPERIMENTAL

Product 33525

Drug: 33525

Placebo

PLACEBO COMPARATOR

Product 33525 Placebo

Drug: Placebo

Interventions

33525DRUG

Daily for 14 days

Active
PlaceboDRUG

Daily for 14 days

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate erythema, moderate scaling, and mild pruritus

You may not qualify if:

  • Pregnancy and allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Warren, Michigan, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Cinncinnati, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Belize City, Belize

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ron Staugaard

    Medicis Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

US(10)BE(1)