Tinea CrurisPhase 3NCT01342315
Topical Antifungal Treatment for Tinea Cruris
A Phase 3 study testing 33525 in people with Tinea Cruris, run by Medicis Global Service Corporation at 21 sites in 5 countries.
Trial summary
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Cruris
- What is being tested?
- 33525
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 483 participants
- Where
- 21 sitesin 5 countries
- Study dates
- May 2011to May 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, mild scaling, and moderate pruritis
Who cannot join
- pregnancy and allergies
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
United States17 sites
Study site
Albuquerque, New Mexico
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
Los Angeles, California
Study site
Lynchburg, Virginia
Study site
Miami, Florida
Study site
Miramar, Florida
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
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 Cruris
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris
- Conditions
- Tinea Cruris
- Being tested
- 33525, Placebo
- Keywords
- Tinea Cruris, antifungal
- Medical subject headings
- Tinea Cruris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
33525Drug
Daily dosing
PlaceboDrug
Daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Product 33525 Receives: Drug: 33525 |
| Placebo | Experimental | 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: 3 weeks post-treatment
Secondary outcomes (1)
Proportion of patients achieving effective treatment
Clinical Cure and Mycological Cure
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 posted27 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CrurisStudies 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
- 483 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
- NCT01342315
- Sponsor's protocol ID
- MP-1000-01
- Status last verified
- Aug 2013
- First submitted
- 25 Apr 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 Cruris
- ClinicalTrials.gov ID
- NCT01342315
- Acronym / sponsor ID
- MP-1000-01
- Conditions
- Tinea Cruris
- Keywords
- Tinea Cruris, antifungal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Apr 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.
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris
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 | Experimental | 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, mild scaling, and moderate pruritis
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 dosing | Drug | Active |
| PlaceboDaily dosing | Drug | Placebo |
Primary outcome
Proportion of patients achieving complete clearance
Time frame: 3 weeks post-treatment
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
1 secondary outcome
Proportion of patients achieving effective treatment
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 28 Aug 2013.
Related trials for Tinea Cruris
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Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
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In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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Not yet recruitingPhase 4
Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail
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A Pilot Study to Evaluate the Therapeutic Efficacy of Intra-Lesional Immunotherapy in Patients Aged 10-60 Years With Recalcitrant Tinea Cruris and Corporis
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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
21 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 33525 in people with Tinea Cruris, run by Medicis Global Service Corporation at 21 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 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 21 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?
Proportion of patients achieving complete clearance (time frame: 3 weeks post-treatment). 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.