Tinea PedisPhase 2NCT00869336
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
A Phase 2 study testing Luliconazole Cream 1% - 2 wks and Luliconazole Cream 1% - 4 wks in people with Tinea Pedis, run by Tinea Pharmaceuticals at 4 sites in United States.
Trial summary
To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment. 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?
- Luliconazole Cream 1% - 2 wks and Luliconazole Cream 1% - 4 wks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 2
- 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
- Subjects of either gender must be 12 years of age or older.
- Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
- Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
- Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception
Who cannot join
- Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
- Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- Subjects who are immunocompromised (due to disease, e.g., HIV or medications
- Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
- Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
- Subjects using the following medications:
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- topical antifungal agent within 30 days of the baseline visit
- systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)
- topical corticosteroid in treatment area(s) within 30 days of the baseline visit.
- systemic corticosteroids within 30 days of the baseline visit;
- any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Austin, Texas, 78759
Study site
College Station, Texas, 77840
Study site
Fridley, Minnesota, 55432
Study site
Portland, Oregon, 97210
About this study
Official title: Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis
To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
- Conditions
- Tinea Pedis
- Being tested
- Luliconazole Cream 1% - 2 wks, Placebo Comparator -2 wks, Luliconazole Cream 1% - 4 wks, Placebo Comparator - 4 wks
- Keywords
- Tinea Pedis, Athlete's Foot
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luliconazole Cream 1% - 2 wksDrug
Topical cream applied daily for 2 weeks
Placebo Comparator -2 wksDrug
Placebo cream applied daily for 2 weeks
Luliconazole Cream 1% - 4 wksDrug
Topical cream applied daily for 4 weeks
Placebo Comparator - 4 wksDrug
Placebo cream applied daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Luliconazole Cream 1% - 2 wks | Experimental | Daily treatment with Luliconazole Cream 1% for 2 weeks Receives: Drug: Luliconazole Cream 1% - 2 wks |
| Luliconazole Cream 1% - 4 wks | Experimental | Daily treatment with Luliconazole Cream 1% for 4 weeks Receives: Drug: Luliconazole Cream 1% - 4 wks |
| Placebo Comparator - 2 wks | Placebo comparator | Daily treatment with Vehicle Cream for 2 weeks Receives: Drug: Placebo Comparator -2 wks |
| Placebo Comparator - 4 wks | Placebo comparator | Daily treatment with Vehicle Cream for 4 weeks Receives: Drug: Placebo Comparator - 4 wks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve complete clearance at 2 weeks post treatment
Measured: Two weeks post treatment
Secondary outcomes (1)
Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment
Measured: 2 and 4 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 posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tinea Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869336
- Sponsor's protocol ID
- TP-0801
- Status last verified
- Jun 2011
- First submitted
- 25 Mar 2009
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT00869336
- Acronym / sponsor ID
- TP-0801
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis, Athlete's Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Tinea PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Mar 2009 (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 examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Luliconazole Cream 1% - 2 wks | Experimental | Drug: Luliconazole Cream 1% - 2 wksDaily treatment with Luliconazole Cream 1% for 2 weeks |
| Luliconazole Cream 1% - 4 wks | Experimental | Drug: Luliconazole Cream 1% - 4 wksDaily treatment with Luliconazole Cream 1% for 4 weeks |
| Placebo Comparator - 2 wks | Placebo comparator | Drug: Placebo Comparator -2 wksDaily treatment with Vehicle Cream for 2 weeks |
| Placebo Comparator - 4 wks | Placebo comparator | Drug: Placebo Comparator - 4 wksDaily treatment with Vehicle Cream for 4 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects of either gender must be 12 years of age or older.
- Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
- Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
- Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception
Key exclusion criteria (11 listed)
- Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot;
- Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
- Subjects who are immunocompromised (due to disease, e.g., HIV or medications
- Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
- Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
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 |
|---|---|---|
| Luliconazole Cream 1% - 2 wksTopical cream applied daily for 2 weeks | Drug | Luliconazole Cream 1% - 2 wks |
| Placebo Comparator -2 wksPlacebo cream applied daily for 2 weeks | Drug | Placebo Comparator - 2 wks |
| Luliconazole Cream 1% - 4 wksTopical cream applied daily for 4 weeks | Drug | Luliconazole Cream 1% - 4 wks |
| Placebo Comparator - 4 wksPlacebo cream applied daily for 4 weeks | Drug | Placebo Comparator - 4 wks |
Primary outcome
Proportion of subjects who achieve complete clearance at 2 weeks post treatment
Time frame: Two weeks post treatment
1 secondary outcome
Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment
Time frame: 2 and 4 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 21 Jun 2011.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luliconazole Cream 1% - 2 wks and Luliconazole Cream 1% - 4 wks in people with Tinea Pedis, run by Tinea Pharmaceuticals at 4 sites in United States.
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 11 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 subjects who achieve complete clearance at 2 weeks post treatment (time frame: Two 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 21 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.