Tinea PedisPhase 3NCT01349998
Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
A Phase 3 study testing Product 33525 in people with Tinea Pedis and Tinea Cruris, run by Tinea Pharmaceuticals at 24 sites in 5 countries.
Trial summary
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis, Tinea Cruris, Tinea Corporis
- What is being tested?
- Product 33525
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 24 sitesin 5 countries
- Study dates
- May 2011to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol
Who cannot join
- Pregnancy and allergies. Additional criteria listed in protocol
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
United States20 sites
Study site
Albuquerque, New Mexico
Study site
Augusta, Georgia
Study site
Austin, Texas
Study site
Cincinnati, Ohio
Study site
College Station, Texas
Study site
Evansville, Indiana
Study site
Fremont, California
Study site
Goodletsville, Tennessee
Study site
Hershey, Pennsylvania
Study site
Los Angeles, California
Study site
Lynchburg, Virginia
Study site
Miami, Florida
Study site
Miramar, Florida
Study site
Omaha, Nebraska
Study site
Paramus, New Jersey
Study site
Philadelphia, Pennsylvania
Study site
Plano, Texas
Study site
San Antonio, Texas
Study site
St. Petersburg, Florida
Study site
Warren, Michigan
Belize1 site
Study site
Belize City, Belize District
About this study
Official title: An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.
- Conditions
- Tinea Pedis, Tinea Cruris, Tinea Corporis
- Being tested
- Product 33525
- Medical subject headings
- Tinea Pedis, Tinea Cruris, Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product 33525Drug
Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis
| Study group | Role | What they receive |
|---|---|---|
| Safety Population | Experimental | Not described Receives: Drug: Product 33525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Adverse Events
To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.
Measured: One Year
Secondary outcomes (1)
Clinical Cure and Mycological Cure
Proportion of patients achieving effective treatment
Measured: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tinea Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349998
- Sponsor's protocol ID
- MP-1005
- Status last verified
- Jan 2013
- First submitted
- 3 May 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris
- ClinicalTrials.gov ID
- NCT01349998
- Acronym / sponsor ID
- MP-1005
- Conditions
- Tinea Pedis, Tinea Cruris, Tinea Corporis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Tinea PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety Population | Experimental | Drug: Product 33525 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol
Key exclusion criteria (1 listed)
- Pregnancy and allergies. Additional criteria listed in protocol
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 |
|---|---|---|
| Product 33525Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis | Drug | Safety Population |
Primary outcome
Number of Subjects with Adverse Events
Time frame: One Year
To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.
1 secondary outcome
Clinical Cure and Mycological Cure
Time frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
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.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Product 33525 in people with Tinea Pedis and Tinea Cruris, run by Tinea Pharmaceuticals at 24 sites in 5 countries.
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 1 inclusion and 1 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Belize, El Salvador, Honduras, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Subjects with Adverse Events (time frame: One Year). 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 23 Jan 2013.