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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802672
• Other study ID #: CPL-302
• Status: Completed
• Phase: Phase 3
• Start date: December 2003
• Est. completion date: May 2004

Study information

• Verified date: October 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects in Each Treatment Group With Therapeutic Success	Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success	6 weeks
Secondary	Proportion of Subjects With Mycological Cure	Mycological Cure (KOH wet mount negative and fungal culture negative	6 weeks
Secondary	Proportion of Subjects With Clinical Cure	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	6 weeks