Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis - Full Text View

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00802672

Purpose

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Condition	Intervention
Tinea Pedis	Drug: Ciclopirox Olamine Cream Drug: Ciclopirox Cream 0.77%-Reference Product Drug: Ciclopirox Olamine Cream-Placebo

MedlinePlus related topics: Athlete's Foot Tinea Infections

Drug Information available for: Ciclopirox Ciclopirox olamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multi-Center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Proportion of subjects in each treatment Group with Therapeutic Success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with Mycological Cure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Proportion of Subjects with Clinical Cure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	561
Study Start Date:	December 2003
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Product: Active Comparator	Drug: Ciclopirox Olamine Cream
Reference Product: Active Comparator	Drug: Ciclopirox Cream 0.77%-Reference Product
Vehicle Product: Placebo Comparator	Drug: Ciclopirox Olamine Cream-Placebo

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female at least 10 years of age, and otherwise healthy
Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
In good health with no clinically significant disease that might have interfered with study evaluations
Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

History of hypersensitivity or allergy to ciclopirox
Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
Had a history of dermatophyte infecton unresponsive to antifungal treatment
Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
Was unwilling to sign the informed consent
Female who was pregnant or lactating

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Perrigo Company ( Linda Gans )
Study ID Numbers:	CPL-302
Study First Received:	December 4, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00802672
Health Authority:	United States: Institutional Review Board

Keywords provided by Perrigo Company:

Tinea Pedis
Ciclopirox Olamine

Study placed in the following topic categories:

Pruritus
Skin Diseases
Clotrimazole
Miconazole
Tioconazole
Foot Diseases
Tinea Pedis

Mycoses
Signs and Symptoms
Skin Diseases, Infectious
Ciclopirox
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Anti-Infective Agents
Skin Manifestations
Foot Dermatoses
Therapeutic Uses

Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009