Tinea PedisPhase 1NCT01519752
A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis
A Phase 1 study testing Oxiconazole Nitrate Cream 1% and Oxiconazole Nitrate Cream 1% (Oxistat®) in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe 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?
- Oxiconazole Nitrate Cream 1% and Oxiconazole Nitrate Cream 1% (Oxistat®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 661 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 1
- 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
- Male or non-pregnant, non-lactating female, 12 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study {e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives}
- A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. (the non-interdigital lesions should not be hyperkeratotic i.e., characteristic of moccasin).
- The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.
Who cannot join
- Females who are pregnant, or lactating or likely to become pregnant during the study.
- Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.
- Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy).
- Participation in a research study in the past 30 days prior to screening/randomization.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis
The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.
- Conditions
- Tinea Pedis
- Being tested
- Oxiconazole Nitrate Cream 1%, Oxiconazole Nitrate Cream 1% (Oxistat®), Placebo
- Keywords
- Tinea Pedis
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiconazole Nitrate Cream 1%Drug
Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
Oxiconazole Nitrate Cream 1% (Oxistat®)Drug
Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
PlaceboDrug
Placebo applied to affected area once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Oxiconazole Nitrate Cream 1% | Experimental | Not described Receives: Drug: Oxiconazole Nitrate Cream 1% |
| Oxiconazole Nitrate Cream 1% (Oxistat®) | Active comparator | Not described Receives: Drug: Oxiconazole Nitrate Cream 1% (Oxistat®) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure
Clinical \& Mycological Cure at 6 weeks
Measured: Day 42
Secondary outcomes (2)
Clinical Cure
Proportion of patients considered a clinical cure at 6 weeks
Measured: Day 42
Mycological Cure
Proportion of patients with both KOH \& culture negative at 6 weeks
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 posted27 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionNov 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519752
- Sponsor's protocol ID
- OXZC 1102
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis
- ClinicalTrials.gov ID
- NCT01519752
- Acronym / sponsor ID
- OXZC 1102
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Jan 2012 (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 objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxiconazole Nitrate Cream 1% | Experimental | Drug: Oxiconazole Nitrate Cream 1% |
| Oxiconazole Nitrate Cream 1% (Oxistat®) | Active comparator | Drug: Oxiconazole Nitrate Cream 1% (Oxistat®) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant, non-lactating female, 12 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study {e.g., condom, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives}
- A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. (the non-interdigital lesions should not be hyperkeratotic i.e., characteristic of moccasin).
- The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.
Key exclusion criteria (4 listed)
- Females who are pregnant, or lactating or likely to become pregnant during the study.
- Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.
- Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy).
- Participation in a research study in the past 30 days prior to screening/randomization.
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 |
|---|---|---|
| Oxiconazole Nitrate Cream 1%Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days | Drug | Oxiconazole Nitrate Cream 1% |
| Oxiconazole Nitrate Cream 1% (Oxistat®)Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days | Drug | Oxiconazole Nitrate Cream 1% (Oxistat®) |
| PlaceboPlacebo applied to affected area once a day for 28 days | Drug | Placebo |
Primary outcome
Therapeutic Cure
Time frame: Day 42
Clinical \& Mycological Cure at 6 weeks
2 secondary outcomes
Clinical Cure
Time frame: Day 42
Mycological Cure
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 22 Jan 2014.
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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 1 study testing Oxiconazole Nitrate Cream 1% and Oxiconazole Nitrate Cream 1% (Oxistat®) in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
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 5 inclusion and 4 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 22 Jan 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Therapeutic Cure (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 22 Jan 2014.