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

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ClinicalTrials.gov Identifier: NCT00802672
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : June 19, 2012
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Padagis LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Tinea Pedis Drug: Ciclopirox Olamine Cream Drug: Loprox Cream 0.77% Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
Study Start Date : December 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Product
Ciclopirox Olamine Cream 0.77%
Drug: Ciclopirox Olamine Cream
topical cream

Active Comparator: Reference Product
Loprox Cream 0.77%
Drug: Loprox Cream 0.77%
topical cream
Other Name: Loprox Cream

Placebo Comparator: Vehicle Product
placebo of test product
Drug: Placebo
topical cream




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Proportion of Subjects With Mycological Cure [ Time Frame: 6 weeks ]
    Mycological Cure (KOH wet mount negative and fungal culture negative

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Responsible Party: Padagis LLC
ClinicalTrials.gov Identifier: NCT00802672    
Other Study ID Numbers: CPL-302
First Posted: December 5, 2008    Key Record Dates
Results First Posted: June 19, 2012
Last Update Posted: October 13, 2021
Last Verified: October 2021
Keywords provided by Padagis LLC:
Tinea Pedis
Ciclopirox Olamine
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Ciclopirox
Antifungal Agents
Anti-Infective Agents