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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2004

Interventions

  • Drug: Ciclopirox Olamine Cream
    • topical cream
  • Drug: Loprox Cream 0.77%
    • topical cream
  • Drug: Placebo
    • topical cream

Arms, Groups and Cohorts

  • Experimental: Test Product
    • Ciclopirox Olamine Cream 0.77%
  • Active Comparator: Reference Product
    • Loprox Cream 0.77%
  • Placebo Comparator: Vehicle Product
    • placebo of test product

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Subjects in Each Treatment Group With Therapeutic Success
    • Time Frame: 6 weeks
    • Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success

Secondary Measures

  • Proportion of Subjects With Mycological Cure
    • Time Frame: 6 weeks
    • Mycological Cure (KOH wet mount negative and fungal culture negative
  • Proportion of Subjects With Clinical Cure
    • Time Frame: 6 weeks
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Padagis LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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