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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

Primary Purpose

Tinea Pedis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Ciclopirox Olamine Topical Suspension

Ciclopirox Topical Suspension 0.77%-Reference Product

Ciclopirox Olamine Topical Suspension-Placebo

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea Pedis, Ciclopirox Olamine

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Product

Reference Product

Vehicle Product

Arm Description

Ciclopirox Olamine Topical Suspension

Loprox® Topical Suspension 0.77%

placebo of test product

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of Subjects With Mycological Cure

Potassium hydroxide [KOH] wet mount negative and fungal culture negative

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

Full Information

NCT ID

NCT00804193

First Posted

December 5, 2008

Last Updated

October 11, 2021

Sponsor

Padagis LLC

1. Study Identification

Unique Protocol Identification Number

NCT00804193

Brief Title

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

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 Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Padagis LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Pedis

Keywords

Tinea Pedis, Ciclopirox Olamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

553 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Product

Arm Type

Experimental

Arm Description

Ciclopirox Olamine Topical Suspension

Arm Title

Reference Product

Arm Type

Active Comparator

Arm Description

Loprox® Topical Suspension 0.77%

Arm Title

Vehicle Product

Arm Type

Placebo Comparator

Arm Description

placebo of test product

Intervention Type

Drug

Intervention Name(s)

Ciclopirox Olamine Topical Suspension

Intervention Description

topical suspension

Intervention Type

Drug

Intervention Name(s)

Ciclopirox Topical Suspension 0.77%-Reference Product

Intervention Description

topical suspension

Intervention Type

Drug

Intervention Name(s)

Ciclopirox Olamine Topical Suspension-Placebo

Intervention Description

topical suspension

Primary Outcome Measure Information:

Title

Proportion of Subjects in Each Treatment Group With Therapeutic Success

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Proportion of Subjects With Mycological Cure

Description

Potassium hydroxide [KOH] wet mount negative and fungal culture negative

Time Frame

6 weeks

Title

Proportion of Subjects With Clinical Cure

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility 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 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

12. IPD Sharing Statement

Learn more about this trial

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

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