Topical Antifungal Treatment for Tinea Pedis | NCT01396811

Studies
Topical Antifungal Treatment for Tinea Pedis

NCT01396811

Sponsor

Medicis Global Service Corporation

Status

Completed

Last Update Posted

Aug 28, 2013Estimated

Enrollment

322Actual

Phase

Phase 3

Conditions

Tinea Pedis

Interventions

33525
Placebo

Countries

United States
Belize

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jul 15, 2011

First Submission Date that Met QC Criteria

Jul 18, 2011

First Posted Date

Jul 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 22, 2013

Certification/Extension First Submitted that Passed QC Review

Jan 22, 2013

Certification/Extension First Posted Date

Jan 23, 2013Estimated

Last Update Submitted Date

Aug 20, 2013

Last Update Posted Date

Aug 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

322Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Product 33525	Drug: 33525
Placebo	Placebo Comparator	Product 33525 Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
33525	Drug	Daily for 14 days	Active
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving complete clearance	Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture	Day 42

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients achieving effective treatment	Clinical Cure and Mycologic Cure	Day 42

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

Pregnancy and allergies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Staugaard	Medicis Pharmaceutical	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Miami	Florida		United States

Condition Browse Module

MeSH Terms

ID	Term
D014008	Tinea Pedis

Ancestor Terms

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided