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Topical Antifungal Treatment for Tinea Cruris

Primary Purpose

Tinea Cruris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
33525
Placebo
Sponsored by
Medicis Global Service Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Cruris focused on measuring Tinea Cruris, antifungal

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

  • pregnancy and allergies

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active

Placebo

Arm Description

Product 33525

Product 33525 Placebo

Outcomes

Primary Outcome Measures

Proportion of patients achieving complete clearance
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures

Proportion of patients achieving effective treatment
Clinical Cure and Mycological Cure

Full Information

First Posted
April 25, 2011
Last Updated
August 20, 2013
Sponsor
Medicis Global Service Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01342315
Brief Title
Topical Antifungal Treatment for Tinea Cruris
Official Title
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicis Global Service Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Cruris
Keywords
Tinea Cruris, antifungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
483 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Product 33525
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Product 33525 Placebo
Intervention Type
Drug
Intervention Name(s)
33525
Intervention Description
Daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily dosing
Primary Outcome Measure Information:
Title
Proportion of patients achieving complete clearance
Description
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
Time Frame
3 weeks post-treatment
Secondary Outcome Measure Information:
Title
Proportion of patients achieving effective treatment
Description
Clinical Cure and Mycological Cure
Time Frame
1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate erythema, mild scaling, and moderate pruritis Exclusion Criteria: pregnancy and allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Staugaard
Organizational Affiliation
Medicis Pharmaceutical
Official's Role
Study Director
Facility Information:
City
Fremont
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Miramar
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Warren
State/Province
Michigan
Country
United States
City
Paramus
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Cincinatti
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Goodletsville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
College Station
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Lynchburg
State/Province
Virginia
Country
United States
City
Belize City
Country
Belize
City
San Salvador
Country
El Salvador
City
San Pedro Sula
Country
Honduras
City
Cidra
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Topical Antifungal Treatment for Tinea Cruris

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