- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804193
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
October 11, 2021 updated by: Padagis LLC
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
553
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Product
Ciclopirox Olamine Topical Suspension
|
topical suspension
|
Active Comparator: Reference Product
Loprox® Topical Suspension 0.77%
|
topical suspension
|
Placebo Comparator: Vehicle Product
placebo of test product
|
topical suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects in Each Treatment Group With Therapeutic Success
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With Mycological Cure
Time Frame: 6 weeks
|
Potassium hydroxide [KOH] wet mount negative and fungal culture negative
|
6 weeks
|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
December 5, 2008
First Submitted That Met QC Criteria
December 5, 2008
First Posted (Estimate)
December 8, 2008
Study Record Updates
Last Update Posted (Actual)
October 27, 2021
Last Update Submitted That Met QC Criteria
October 11, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPL-402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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