Tinea CorporisPhase 4NCT02466867
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
A Phase 4 study testing Naftin® Cream, 2% (younger pediatric cohort) and Naftin® Cream, 2% (older pediatric cohort) in people with Tinea Corporis, run by Merz North America, Inc. at 3 sites in 3 countries.
Trial summary
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Tinea Corporis
- What is being tested?
- Naftin® Cream, 2% (younger pediatric cohort) and Naftin® Cream, 2% (older pediatric cohort)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 4
- 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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
- Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
- Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.
Who cannot join
- Tinea infection of the scalp, face, groin, and/or feet.
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
- Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity or other contradictions to study medications or their components.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Merz Investigative Site#001261
College Station, Texas, 77845
Dominican Republic1 site
Merz Investigative Site#180001
Santo Domingo
About this study
Official title: An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
- Conditions
- Tinea Corporis
- Being tested
- Naftin® Cream, 2% (younger pediatric cohort), Naftin® Cream, 2% (older pediatric cohort)
- Keywords
- Ringworm
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naftin® Cream, 2% (younger pediatric cohort)Drug
Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
Naftin® Cream, 2% (older pediatric cohort)Drug
Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.
| Study group | Role | What they receive |
|---|---|---|
| Naftin® Cream, 2% (younger pediatric cohort) | Experimental | Subject aged 2 years to 5 years, 11 months with tinea corporis Receives: Drug: Naftin® Cream, 2% (younger pediatric cohort) |
| Naftin® Cream, 2% (older pediatric cohort) | Experimental | Subject aged 6 years to 11 years, 11 months with tinea corporis Receives: Drug: Naftin® Cream, 2% (older pediatric cohort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
Measured: 2 weeks
Secondary outcomes (3)
Evaluate plasma PK single and multiple dose PK variables
tmax and tmax,ss
Measured: 2 weeks
Evaluate trough plasma PK concentration
Ctrough, ttrough,max, Ctrough,max
Measured: 2 weeks
Evaluate urine PK single and multiple dose variables
Ae0-24, fe, CLR, AEt,ss
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CorporisStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan B. Fleischer, MD, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466867
- Sponsor's protocol ID
- MUS90200_4025_1
- Status last verified
- Oct 2016
- First submitted
- 29 Oct 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 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 Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
- ClinicalTrials.gov ID
- NCT02466867
- Acronym / sponsor ID
- MUS90200_4025_1
- Conditions
- Tinea Corporis
- Keywords
- Ringworm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jun 2015 (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.
This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naftin® Cream, 2% (younger pediatric cohort) | Experimental | Drug: Naftin® Cream, 2% (younger pediatric cohort)Subject aged 2 years to 5 years, 11 months with tinea corporis |
| Naftin® Cream, 2% (older pediatric cohort) | Experimental | Drug: Naftin® Cream, 2% (older pediatric cohort)Subject aged 6 years to 11 years, 11 months with tinea corporis |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
- Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
- Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.
Key exclusion criteria (4 listed)
- Tinea infection of the scalp, face, groin, and/or feet.
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
- Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
- Subjects with a known hypersensitivity or other contradictions to study medications or their components.
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 |
|---|---|---|
| Naftin® Cream, 2% (younger pediatric cohort)Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months. | Drug | Naftin® Cream, 2% (younger pediatric cohort) |
| Naftin® Cream, 2% (older pediatric cohort)Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months. | Drug | Naftin® Cream, 2% (older pediatric cohort) |
Primary outcome
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
Time frame: 2 weeks
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
3 secondary outcomes
Evaluate plasma PK single and multiple dose PK variables
Time frame: 2 weeks
Evaluate trough plasma PK concentration
Time frame: 2 weeks
Evaluate urine PK single and multiple dose variables
Time frame: 2 weeks
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 Oct 2016.
Related trials for Tinea Corporis
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Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
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RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Evaluations of Resistant Dermatophytosis
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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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RecruitingPhase 4
Comparing the Efficacy of Oral Fluconazole Versus Oral Itraconazole in Treating Resistant Tinea 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.
Alan B. Fleischer, MD study director
Merz North America, Inc.
3 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 Naftin® Cream, 2% (younger pediatric cohort) and Naftin® Cream, 2% (older pediatric cohort) in people with Tinea Corporis, run by Merz North America, Inc. at 3 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 4 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis (time frame: 2 weeks). 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 Oct 2016.