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

NCT00802672 | Completed Phase 3 Results

• 1 other identifier: CPL-302
• Study Type: interventional
• Target: 561
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinea Pedis

Keywords

Tinea Pedis; Ciclopirox Olamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of Subjects With Mycological Cure

  6 weeks

• Proportion of Subjects With Clinical Cure

  6 weeks

Study Arms (3)

Test Product

EXPERIMENTAL

Ciclopirox Olamine Cream 0.77%

Drug: Ciclopirox Olamine Cream

Reference Product

ACTIVE COMPARATOR

Loprox Cream 0.77%

Drug: Loprox Cream 0.77%

Vehicle Product

PLACEBO COMPARATOR

placebo of test product

Drug: Placebo

Interventions

Ciclopirox Olamine Cream DRUG

topical cream

Test Product

Loprox Cream 0.77% DRUG

topical cream

Also known as: Loprox Cream

Reference Product

Placebo DRUG

topical cream

Vehicle Product

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo Company

jonathan.schwartz@perrigo.com

718-960-0119

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: October 13, 2021
• Results First Posted: June 19, 2012

Record last verified: 2021-10