Tinea PedisPhase 4NCT01712360
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
A Phase 4 study testing NAFT500 (pediatric), NAFT600 (pediatric) and NAFT500 (adult) in people with Tinea Pedis and Tinea Cruris, run by Merz North America, Inc. at 4 sites in 3 countries.
Trial summary
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Tinea Pedis, Tinea Cruris
- What is being tested?
- NAFT500 (pediatric), NAFT600 (pediatric) and NAFT500 (adult)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2012to Nov 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.
- Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.
Who cannot join
- A known hypersensitivity to study medications or their components
- Any severe condition of Tinea pedis (incapacitating)
- Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis
- Positive pregnancy test
- Any history or current evidence (physical or laboratory) of anemia
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Merz Investigative Site #001272
Austin, Texas, 78759
Merz Investigative Site #001261
College Station, Texas, 77802
Dominican Republic1 site
Merz Investigative Site #180001
Santo Domingo, Santo Domingo Province
Honduras1 site
Merz Investigative Site #504001
San Pedro Sula, San Pedro Sula
About this study
Official title: An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
Read the detailed description
Study population, diagnosis, and main criteria for inclusion:
Tinea pedis and Tinea cruris (NAFT-500):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
Tinea pedis (NAFT-600):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
- Conditions
- Tinea Pedis, Tinea Cruris
- Being tested
- NAFT500 (pediatric), NAFT600 (pediatric), NAFT500 (adult), NAFT600 (adult)
- Keywords
- Tinea Pedis, Tinea Cruris, Athlete foot, Jock itch
- Medical subject headings
- Tinea Pedis, Tinea Cruris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFT500 (pediatric)Drug
Also called NAFT500, naftifine, naftifine hydrochloride
Applied to both feet and groin area
NAFT600 (pediatric)Drug
Also called NAFT600, naftifine, naftifine hydrochloride
Applied to both feet only
NAFT500 (adult)Drug
Also called NAFT500, naftifine, naftifine hydrochloride
Applied to both feet and groin area
NAFT600 (adult)Drug
Also called NAFT600, naftifine, naftifine hydrochloride
Applied to both feet
| Study group | Role | What they receive |
|---|---|---|
| NAFT500 (pediatric) | Experimental | Topical once a day for two weeks Receives: Drug: NAFT500 (pediatric) |
| NAFT600 (pediatric) | Experimental | Topical once a day for two weeks Receives: Drug: NAFT600 (pediatric) |
| NAFT500 (adult) | Experimental | Topical once a day for two weeks Receives: Drug: NAFT500 (adult) |
| NAFT600 (adult) | Experimental | Topical once a day for two weeks Receives: Drug: NAFT600 (adult) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
Measured: Day 1 and Day 14
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.
Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:
- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
Measured: Day 1 and Day 14
Secondary outcomes (2)
Efficacy Variables
Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
- Complete cure
- Treatment effectiveness
- Mycological cure
- Clinical success
- Clinical cure
Measured: Day 28
Efficacy Variables
Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).
Efficacy variables to be analyzed:
- Subject satisfaction
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Fleischer, MD, Study director, Merz Pharmaceutical, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712360
- Sponsor's protocol ID
- MUS 90200/1023/0
- Other IDs
- Tinea Pedis and Cruris
- Status last verified
- Jun 2016
- First submitted
- 16 Oct 2012
- Last updated
- 14 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT01712360
- Acronym / sponsor ID
- MUS 90200/1023/0
- Conditions
- Tinea Pedis, Tinea Cruris
- Keywords
- Tinea Pedis, Tinea Cruris, Athlete foot, Jock itch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Posted 14 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
Detailed description
Study population, diagnosis, and main criteria for inclusion:
Tinea pedis and Tinea cruris (NAFT-500):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
Tinea pedis (NAFT-600):
Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NAFT500 (pediatric) | Experimental | Drug: NAFT500 (pediatric)Topical once a day for two weeks |
| NAFT600 (pediatric) | Experimental | Drug: NAFT600 (pediatric)Topical once a day for two weeks |
| NAFT500 (adult) | Experimental | Drug: NAFT500 (adult)Topical once a day for two weeks |
| NAFT600 (adult) | Experimental | Drug: NAFT600 (adult)Topical once a day for two weeks |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.
- Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.
Key exclusion criteria (5 listed)
- A known hypersensitivity to study medications or their components
- Any severe condition of Tinea pedis (incapacitating)
- Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis
- Positive pregnancy test
- Any history or current evidence (physical or laboratory) of anemia
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 |
|---|---|---|
| NAFT500 (pediatric)Also: NAFT500, naftifine, naftifine hydrochlorideApplied to both feet and groin area | Drug | NAFT500 (pediatric) |
| NAFT600 (pediatric)Also: NAFT600, naftifine, naftifine hydrochlorideApplied to both feet only | Drug | NAFT600 (pediatric) |
| NAFT500 (adult)Also: NAFT500, naftifine, naftifine hydrochlorideApplied to both feet and groin area | Drug | NAFT500 (adult) |
| NAFT600 (adult)Also: NAFT600, naftifine, naftifine hydrochlorideApplied to both feet | Drug | NAFT600 (adult) |
Primary outcome
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Time frame: Day 1 and Day 14
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Time frame: Day 1 and Day 14
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
2 secondary outcomes
Efficacy Variables
Time frame: Day 28
Efficacy Variables
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alan Fleischer, MD study director
Merz Pharmaceutical, LLC
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NAFT500 (pediatric), NAFT600 (pediatric) and NAFT500 (adult) in people with Tinea Pedis and Tinea Cruris, run by Merz North America, Inc. at 4 sites in 3 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 2 inclusion and 5 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 14 Jul 2016. 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, Dominican Republic, Honduras. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose (time frame: Day 1 and Day 14). The study lists 2 primary outcomes in all. 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 14 Jul 2016.