Tinea PedisPhase 3NCT01396811
Topical Antifungal Treatment for Tinea Pedis
A Phase 3 study testing 33525 in people with Tinea Pedis, run by Medicis Global Service Corporation at 11 sites in 2 countries.
Trial summary
The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- 33525
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2011to Mar 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
- Moderate erythema, moderate scaling, and mild pruritus
Who cannot join
- Pregnancy and allergies
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Study site
Augusta, Georgia
Study site
Cinncinnati, Ohio
Study site
Evansville, Indiana
Study site
Hackensack, New Jersey
Study site
High Point, North Carolina
Study site
Miami, Florida
Study site
Miramar, Florida
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Warren, Michigan
Belize1 site
Study site
Belize City
About this study
Official title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis
The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.
- Conditions
- Tinea Pedis
- Being tested
- 33525, Placebo
- Keywords
- Tinea Pedis, Antifungal
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
33525Drug
Daily for 14 days
PlaceboDrug
Daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Product 33525 Receives: Drug: 33525 |
| Placebo | Placebo comparator | Product 33525 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving complete clearance
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
Measured: Day 42
Secondary outcomes (1)
Proportion of patients achieving effective treatment
Clinical Cure and Mycologic Cure
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionMar 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Staugaard, Study director, Medicis Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396811
- Sponsor's protocol ID
- MP-1000-03
- Status last verified
- Aug 2013
- First submitted
- 15 Jul 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT01396811
- Acronym / sponsor ID
- MP-1000-03
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis, Antifungal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Jul 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 determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: 33525Product 33525 |
| Placebo | Placebo comparator | Drug: PlaceboProduct 33525 Placebo |
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)
- Moderate erythema, moderate scaling, and mild pruritus
Key exclusion criteria (1 listed)
- Pregnancy and allergies
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 |
|---|---|---|
| 33525Daily for 14 days | Drug | Active |
| PlaceboDaily for 14 days | Drug | Placebo |
Primary outcome
Proportion of patients achieving complete clearance
Time frame: Day 42
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
1 secondary outcome
Proportion of patients achieving effective treatment
Time frame: Day 42
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 28 Aug 2013.
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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.
Ron Staugaard study director
Medicis Pharmaceutical
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 33525 in people with Tinea Pedis, run by Medicis Global Service Corporation at 11 sites in 2 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belize. 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. 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?
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?
Proportion of patients achieving complete clearance (time frame: Day 42). 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 28 Aug 2013.