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This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.
This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFT-600 ( naftin 2 % gel) | Experimental | Topical; applied once daily for two weeks |
|
| Placebo | Placebo Comparator | Topical; applied once daily for two weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAFT-600 (naftin 2 % gel) | Drug | Topical; applied once daily for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Cure of Interdigital Tinea Pedis | The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus. | Visit 4/ Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrency Parrish, MD | Paddington Testing Co., Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Tucson | Arizona | 85710 | United States | ||
| T. Joseph Raoof, MD, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAFT-600 | Topical; applied once daily for two weeks |
| FG001 | Placebo | Topical; applied once daily for two weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Topical; applied once daily for two weeks. |
|
| Visit 4/ Week 6 |
| Encino |
| California |
| 91436 |
| United States |
| Walter K. Nahm, MD, PhD, Inc. | San Diego | California | 92123 | United States |
| Colorado Medical Research Center | Denver | Colorado | 80210 | United States |
| Longmont Clinic, PC | Longmont | Colorado | 80501 | United States |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | United States |
| Lake Washington Foot and Ankle Center | Melbourne | Florida | 32935 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Hudson Dermatology | Evansville | Indiana | 47714 | United States |
| Department of Veterans Affairs | Minneapolis | Minnesota | 55417 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Radiant Research, Inc | Cincinnati | Ohio | 45249 | United States |
| Radiant Research, Inc. | Columbus | Ohio | 43212 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| Temple University- School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina | 29681 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Endeavor Clinical Trials, PA | San Antonio | Texas | 78229 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| The Education and Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Madison Skin and Research, Inc | Madison | Wisconsin | 53719 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Evaluation Set (SES) which is the population of subjects who receive at least one dose of study medication is used.
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| ID | Title | Description |
|---|---|---|
| BG000 | NAFT-600 | Topical; applied once daily for two weeks |
| BG001 | Placebo | Topical; applied once daily for two weeks. |
| BG002 | 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 | Complete Cure of Interdigital Tinea Pedis | The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus. | Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment. | Posted | Number | percentage of subjects | Visit 4/ Week 6 |
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| Secondary | Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture. | Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population. | Posted | Number | percentage of subjects | Visit 4/ Week 6 |
|
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Adverse Events were collected up to 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-600 | Topical; applied once daily for two weeks | 1 | 572 | 16 | 572 | ||
| EG001 | Placebo | Topical; applied once daily for two weeks. | 2 | 287 | 5 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urethral Stenosis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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Institution and Principal Investigator agreed not to individually publish or assist other person or entity with any articles, papers, and/or make presentations, speeches referring to the protocol, clinical trial data, the study, or the study drug or any data, results, materials, or information generated or obtained by the Institution or the Principal Investigator without the prior written consent of Merz, which consent may be withheld in the sole discretion of Merz.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefan Plaum, MD Associate Medical Director | Merz Pharmaceuticals, LLC | 800-334-0514 | clinicaltrials@merzusa.com |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| 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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| ID | Term |
|---|---|
| C029178 | naftifine |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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