Tinea PedisPhase 3NCT00750139
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
A Phase 3 study testing NAFT-500 and Naftin 1% in people with Tinea Pedis and Athlete's Foot, run by Merz North America, Inc. at 17 sites in United States.
Trial summary
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis, Athlete's Foot
- What is being tested?
- NAFT-500 and Naftin 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 707 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2008to Dec 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Review and sign a statement of Informed Consent and HIPAA authorization.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test.
- Presence of 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.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
- Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
- Subject must be able to understand the requirements of the study and willing to comply with the study requirements.
Who cannot join
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) 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 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.
- Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
Show all 17Show fewer
- Current diagnosis of immunocompromising conditions.
- Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
- Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis, or bacterial skin infection.
- Extremely severe tinea pedis (incapacitating).
- Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study (females who are surgically sterilized or post menopausal for at least 2 years are not considered to be of childbearing potential).For the purposes of this study, acceptable forms of birth control include: oral contraceptives, contraceptive patches/implants, double barrier methods (e.g., use of condom and spermicide), IUD, and abstinence with second acceptable method should subject become sexually active.
- Subjects using the following medications:
- Topical anti-fungal therapy, foot/shoe powders, or topical corticosteroids applied to the feet within 14 days prior to randomization. Topical terbinafine, butenafine,and naftifine within 30 days prior to randomization
- Oral anti-fungal therapies 3 months (8 months for oral terbinafine) prior to randomization
- Systemic antibiotic or corticosteroid treatment within 30 days of randomization
- Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.
- Investigational drug within 30 days of randomization
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Radiant Research
Birmingham, Alabama, 35209
Glazer Dermatology
Buffalo Grove, Illinois, 60089
J & S Studies
College Station, Texas, 77845
Research Across America
Dallas, Texas, 75234
Haber Dermatology
Euclid, Ohio, 44118
Silverton Skin Institute
Grand Blanc, Michigan, 48439
Zoe Draelos, MD
High Point, North Carolina, 27262
Dr. Felix Sigal
Los Angeles, California, 90010-3209
FXM Research
Miami, Florida, 33175
FXM Research
Miramar, Florida, 33027
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Tulane University Health Services
New Orleans, Louisiana, 70112
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107
Research Across America
Plano, Texas, 75093
Oregon Dermatology and Research Center
Portland, Oregon, 97210
University of California San Francisco, Dept of Dermatology
San Francisco, California, 94115
About this study
Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Pedis
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).
Read the detailed description
To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.
- Conditions
- Tinea Pedis, Athlete's Foot
- Being tested
- NAFT-500, Placebo 2-weeks, Naftin 1%, Placebo 4-weeks
- 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.
NAFT-500Drug
topical cream 1 application every day up to 4 weeks weeks
Placebo 2-weeksDrug
placebo cream 1 application every day for up to 4 weeks
Naftin 1%Drug
topical allylamine cream applied once a day for up to 4 weeks
Placebo 4-weeksDrug
topical placebo cream applied once a day for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Naftin 2% cream applied daily for 2 weeks Receives: Drug: NAFT-500 |
| 2 | Placebo comparator | Placebo cream applied daily for two weeks Receives: Drug: Placebo 2-weeks |
| 3 | Active comparator | Active comparator applied daily for 4 weeks Receives: Drug: Naftin 1% |
| 4 | Placebo comparator | placebo cream applied daily for 4 weeks Receives: Drug: Placebo 4-weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Complete Cure at Week 6.
The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.
The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.
Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.
Measured: Week 6
Secondary outcomes (1)
Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Parish, MD, Principal investigator, Paddington Testing Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750139
- Sponsor's protocol ID
- MUS 90200-0736/1
- Status last verified
- Apr 2013
- First submitted
- 8 Sep 2008
- Last updated
- 26 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parish LC, Parish JL, Routh HB, Fleischer AB Jr, Avakian EV, Plaum S, Hardas B. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011 Nov;10(11):1282-8.
PubMed 22052309
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT00750139
- Acronym / sponsor ID
- MUS 90200-0736/1
- Conditions
- Tinea Pedis, Athlete's Foot
- Keywords
- Tinea Pedis, Athlete's foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Posted 29 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).
Detailed description
To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NAFT-500Naftin 2% cream applied daily for 2 weeks |
| 2 | Placebo comparator | Drug: Placebo 2-weeksPlacebo cream applied daily for two weeks |
| 3 | Active comparator | Drug: Naftin 1%Active comparator applied daily for 4 weeks |
| 4 | Placebo comparator | Drug: Placebo 4-weeksplacebo cream applied daily for 4 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Review and sign a statement of Informed Consent and HIPAA authorization.
- For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).
- Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test.
- Presence of 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.
- KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
Key exclusion criteria (17 listed)
- A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) 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 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.
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 |
|---|---|---|
| NAFT-500topical cream 1 application every day up to 4 weeks weeks | Drug | 1 |
| Placebo 2-weeksplacebo cream 1 application every day for up to 4 weeks | Drug | 2 |
| Naftin 1%topical allylamine cream applied once a day for up to 4 weeks | Drug | 3 |
| Placebo 4-weekstopical placebo cream applied once a day for up to 4 weeks | Drug | 4 |
Primary outcome
Percentage of Subjects With Complete Cure at Week 6.
Time frame: Week 6
The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.
1 secondary outcome
Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22052309Parish LC, Parish JL, Routh HB, Fleischer AB Jr, Avakian EV, Plaum S, Hardas B. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011 Nov;10(11):1282-8.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
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.
Lawrence Parish, MD principal investigator
Paddington Testing Company
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAFT-500 and Naftin 1% in people with Tinea Pedis and Athlete's Foot, run by Merz North America, Inc. at 17 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 7 inclusion and 17 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Jan 2013). 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?
Percentage of Subjects With Complete Cure at Week 6. (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750139, which also lists 1 linked publication.
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 26 Apr 2013.