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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Naftin 2% cream applied daily for 2 weeks |
|
| 2 | Placebo Comparator | Placebo cream applied daily for two weeks |
|
| 3 | Active Comparator | Active comparator applied daily for 4 weeks |
|
| 4 | Placebo Comparator | placebo cream applied daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAFT-500 | Drug | topical cream 1 application every day up to 4 weeks weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Parish, MD | Paddington Testing Company | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | United States | ||
| Dr. Felix Sigal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22052309 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAFT-500 | Naftin 2% Cream applied daily for 2 weeks |
| FG001 | Placebo 2-wks | Placebo applied daily for 2-weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo 2-weeks |
| Drug |
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-weeks | Drug | topical placebo cream applied once a day for up to 4 weeks |
|
| Los Angeles |
| California |
| 90010-3209 |
| United States |
| University of California San Francisco, Dept of Dermatology | San Francisco | California | 94115 | United States |
| FXM Research | Miami | Florida | 33175 | United States |
| FXM Research | Miramar | Florida | 33027 | United States |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | United States |
| Tulane University Health Services | New Orleans | Louisiana | 70112 | United States |
| Silverton Skin Institute | Grand Blanc | Michigan | 48439 | United States |
| Zoe Draelos, MD | High Point | North Carolina | 27262 | United States |
| Haber Dermatology | Euclid | Ohio | 44118 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Paddington Testing Company | Philadelphia | Pennsylvania | 19103 | United States |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| J & S Studies | College Station | Texas | 77845 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| FG002 |
| Naftin 1% |
Naftin 1% active comparator applied daily for 4 weeks |
| FG003 | Placebo 4-wks | Placebo cream applied daily for 4 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NAFT-500 | Naftin 2% Cream applied daily for 2 weeks |
| BG001 | Placebo 2-wks | Placebo applied daily for 2-weeks |
| BG002 | Naftin 1% | Naftin 1% active comparator applied daily for 4 weeks |
| BG003 | Placebo 4-wks | Placebo cream applied daily for 4 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment. | Posted | Number | percentage of subjects with complete cur | Week 6 |
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| Secondary | 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. | This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment. | Posted | Number | percentage of Subjects | Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAFT-500 | Naftin 2% Cream applied daily for 2 weeks | 0 | 234 | 38 | 234 | ||
| EG001 | Placebo 2-wks | Placebo applied daily for 2-weeks | 0 | 118 | 22 | 118 | ||
| EG002 | Naftin 1% | Naftin 1% active comparator applied daily for 4 weeks | 1 | 236 | 31 | 236 | ||
| EG003 | Placebo 4-wks | Placebo cream applied daily for 4 weeks | 0 | 119 | 26 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Application Site Irritation | General disorders |
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| Application Site Pruritus | General disorders |
| |||
| Pain | General disorders |
| |||
| Application Site Dryness | General disorders |
| |||
| Blood Creatinine Increased | Investigations |
| |||
| Alanine Aminotransferase Increased | Investigations |
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| Blood Glucose Increased | Investigations |
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| Protein Urine Present | Investigations |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
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Institution and Principal Investigator agree not to individually publish the results of the Study. Institution and Principal Investigator may, however, upon written notice to Merz participate in a joint, multicenter publication of the Study results with other investigators and/or institutions, provided that the manuscript or abstract is first reviewed by Merz.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Medical Director- Dermatology | Merz Pharmaceuticals, LLC | 800-334-0514 |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| The second primary efficacy hypotheses tests are: H02: p2 ≤ P02 vs. H2: P2 > p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively | Cochran-Mantel-Haenszel | 0.001 | The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025 | 95 | No | Superiority or Other |
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