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

NCT00804193 | Completed Results

• 1 other identifier: CPL-402
• Study Type: interventional
• Target: 553
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tinea Pedis

Keywords

Tinea Pedis; Ciclopirox Olamine

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects in Each Treatment Group With Therapeutic Success

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

  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 Topical Suspension

Drug: Ciclopirox Olamine Topical Suspension

Reference Product

ACTIVE COMPARATOR

Loprox® Topical Suspension 0.77%

Drug: Ciclopirox Topical Suspension 0.77%-Reference Product

Vehicle Product

PLACEBO COMPARATOR

placebo of test product

Drug: Ciclopirox Olamine Topical Suspension-Placebo

Interventions

Ciclopirox Olamine Topical Suspension DRUG

topical suspension

Test Product

Ciclopirox Topical Suspension 0.77%-Reference Product DRUG

topical suspension

Reference Product

Ciclopirox Olamine Topical Suspension-Placebo DRUG

topical suspension

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 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

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

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: not applicable
• 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 5, 2008
• First Posted: December 8, 2008
• Study Start: June 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: April 1, 2005
• Last Updated: October 27, 2021
• Results First Posted: December 17, 2012

Record last verified: 2021-10