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The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFT-600 ( naftin 2 % gel) | Experimental |
| |
| Placebo | Placebo Comparator |
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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 |
|---|---|---|
| Lawrence Parish, MD | Paddington Testing Co., Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Foot & Ankle Specialists, LLC | Phoenix | Arizona | 85015 | United States | ||
| Skin Surgery Medical Group, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAFT-600 | NAFT-600 : Topical; applied once daily for two weeks |
| FG001 | Placebo | 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. |
| San Diego |
| California |
| 92117 |
| United States |
| UCSF Dermatology Research | San Francisco | California | 94115 | United States |
| The Savin Center, PC | New Haven | Connecticut | 06511 | United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Miami Dermatology Research Institute, LLC | North Miami Beach | Florida | 33162 | United States |
| Radiant Research, Inc. | Pinellas Park | Florida | 33781 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| Physician Skin Care | Louisville | Kentucky | 40217 | United States |
| Michigan Center for Skin Care Research | Clinton Township | Michigan | 48038 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432-3133 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Paddington Testing Co., Inc. | Philadelphia | Pennsylvania | 19103 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Endeavor Clinical Trials, PA | San Antonio | Texas | 78229 | United States |
| Advanced Medical Concepts, PSC | Cidra | PR | 00739 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Evaluation Set (SES) which is the population of subjects who received at least one dose of study medication was used.
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| ID | Title | Description |
|---|---|---|
| BG000 | NAFT-600 | NAFT-600 : Topical; applied once daily for two weeks |
| BG001 | Placebo | Placebo : Topical; applied once daily for two weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| 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 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 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 | NAFT-600 : Topical; applied once daily for two weeks | 2 | 571 | 13 | 571 | ||
| EG001 | Placebo | Placebo : Topical; applied once daily for two weeks | 2 | 284 | 2 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skull Fractured Base | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | 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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| Puerto Rico |
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