Tinea CorporisPhase 4NCT02227290
Pediatric Subjects With Tinea Corporis
A Phase 4 study testing Naftin Cream in people with Tinea Corporis, run by Merz North America, Inc. at 19 sites in 5 countries.
Trial summary
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinea Corporis
- What is being tested?
- Naftin Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Aug 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
- Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
- KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.
Who cannot join
- Tinea infection of the face, scalp, groin, and/or feet
- A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
- Subjects with abnormal findings- physical or laboratory- that are 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.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
- Uncontrolled diabetes mellitus.
Show all 11Show fewer
- Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
- Current diagnosis of immunocompromising conditions.
- Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
- Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States14 sites
Investigative Site# 0010320
Encino, California, 91436
Merz Investigative Site#001313
Fremont, California, 94538
Investigative Site# 0010319
Gresham, Oregon, 97030
Merz Investigative Site#001314
Henderson, Nevada, 89074
Merz Investigative Site#001312
Miami, Florida, 33144
Merz Investigative Site#001311
Miami, Florida, 33175
Merz Investigative Site #001310
Miramar, Florida, 33027
Merz Investigative Site#001097
Nashville, Tennessee, 37215
Merz Investigative Site#001309
Omaha, Nebraska, 68114
Merz Investigative Site#001126
Raleigh, North Carolina, 27612
Merz Investigative Site#001307
Saint Joseph, Missouri, 64506
Merz Investigative Site#001301
San Diego, California, 92102
Merz Investigative Site#001316
Tucson, Arizona, 85712
Merz Investigative Site#001293
Winston-Salem, North Carolina, 27104
Dominican Republic2 sites
Merz Investigative Site#180002
San Cristobal
Merz Investigative Site# 180001
Santo Domingo
About this study
Official title: A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
Read the detailed description
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
- Conditions
- Tinea Corporis
- Being tested
- Naftin Cream, Placebo Cream
- Keywords
- Tinea Corporis, 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 CreamDrug
Placebo CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| Naftin Cream, 2% | Experimental | Once Daily Receives: Drug: Naftin Cream |
| Placebo Cream | Placebo comparator | Once Daily Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy
Complete cure defined by negative KOH result and negative dermatophyte culture
Measured: Day 21
Secondary outcomes (1)
Secondary Efficacy
Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 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 North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227290
- Sponsor's protocol ID
- MUS90200_4024_1
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 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
- A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
- ClinicalTrials.gov ID
- NCT02227290
- Acronym / sponsor ID
- MUS90200_4024_1
- Conditions
- Tinea Corporis
- Keywords
- Tinea Corporis, Ringworm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Aug 2014 (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 study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
Detailed description
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naftin Cream, 2% | Experimental | Drug: Naftin CreamOnce Daily |
| Placebo Cream | Placebo comparator | Drug: Placebo CreamOnce Daily |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
- Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
- KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.
Key exclusion criteria (11 listed)
- Tinea infection of the face, scalp, groin, and/or feet
- A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
- Subjects with abnormal findings- physical or laboratory- that are 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.
- Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
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 | Drug | Naftin Cream, 2% |
| Placebo Cream | Drug | Placebo Cream |
Primary outcome
Primary Efficacy
Time frame: Day 21
Complete cure defined by negative KOH result and negative dermatophyte culture
1 secondary outcome
Secondary Efficacy
Time frame: Day 21
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.
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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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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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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 Fleischer, MD study director
Merz North America, Inc.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naftin Cream in people with Tinea Corporis, run by Merz North America, Inc. at 19 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 3 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 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 19 sites in United States, Dominican Republic, Honduras, Panama, 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. 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 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?
Primary Efficacy (time frame: Day 21). 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.