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Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00804193
First received: December 5, 2008
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 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 Topical Suspension
Drug: Ciclopirox Topical Suspension 0.77%-Reference Product
Drug: Ciclopirox Olamine Topical Suspension-Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis

Resource links provided by NLM:

U.S. FDA Resources

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 ]
    Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure


Secondary Outcome Measures:
  • Proportion of Subjects With Mycological Cure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Potassium hydroxide [KOH] wet mount negative and fungal culture negative

  • Proportion of Subjects With Clinical Cure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis


Enrollment: 553
Study Start Date: June 2004
Study Completion Date: April 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Product
Ciclopirox Olamine Topical Suspension
 Drug: Ciclopirox Olamine Topical Suspension
topical suspension
Active Comparator: Reference Product
Loprox® Topical Suspension 0.77%
 Drug: Ciclopirox Topical Suspension 0.77%-Reference Product
topical suspension
Placebo Comparator: Vehicle Product
placebo of test product
 Drug: Ciclopirox Olamine Topical Suspension-Placebo
topical suspension

  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 infection 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

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00804193     History of Changes
Other Study ID Numbers: CPL-402
Study First Received: December 5, 2008
Results First Received: September 10, 2012
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
Tinea Pedis
Ciclopirox Olamine

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
 Pruritus
Skin Manifestations
Signs and Symptoms
Ciclopirox
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013