Tinea PedisPhase 3NCT00802672
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
A Phase 3 study testing Ciclopirox Olamine Cream and Loprox Cream 0.77% in people with Tinea Pedis, run by Padagis LLC.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Ciclopirox Olamine Cream and Loprox Cream 0.77%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 561 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to May 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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
- Being tested
- Ciclopirox Olamine Cream, Loprox Cream 0.77%, Placebo
- Keywords
- Tinea Pedis, Ciclopirox Olamine
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclopirox Olamine CreamDrug
topical cream
Loprox Cream 0.77%Drug
Also called Loprox Cream
topical cream
PlaceboDrug
topical cream
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Ciclopirox Olamine Cream 0.77% Receives: Drug: Ciclopirox Olamine Cream |
| Reference Product | Active comparator | Loprox Cream 0.77% Receives: Drug: Loprox Cream 0.77% |
| Vehicle Product | Placebo comparator | placebo of test product Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (2)
Proportion of Subjects With Mycological Cure
Mycological Cure (KOH wet mount negative and fungal culture negative
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2003
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802672
- Sponsor's protocol ID
- CPL-302
- Status last verified
- Oct 2021
- First submitted
- 4 Dec 2008
- Last updated
- 13 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00802672
- Acronym / sponsor ID
- CPL-302
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis, Ciclopirox Olamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Ciclopirox Olamine CreamCiclopirox Olamine Cream 0.77% |
| Reference Product | Active comparator | Drug: Loprox Cream 0.77%Loprox Cream 0.77% |
| Vehicle Product | Placebo comparator | Drug: Placeboplacebo of test product |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciclopirox Olamine Creamtopical cream | Drug | Test Product |
| Loprox Cream 0.77%Also: Loprox Creamtopical cream | Drug | Reference Product |
| Placebotopical cream | Drug | Vehicle Product |
Primary outcome
Proportion of Subjects in Each Treatment Group With Therapeutic Success
Time frame: 6 weeks
Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success
2 secondary outcomes
Proportion of Subjects With Mycological Cure
Time frame: 6 weeks
Proportion of Subjects With Clinical Cure
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclopirox Olamine Cream and Loprox Cream 0.77% in people with Tinea Pedis, run by Padagis LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects in Each Treatment Group With Therapeutic Success (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.