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A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.
To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | placebo |
|
| 1 | Experimental | NAFT-500 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAFT-500 | Drug | topical cream application up to 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects | Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done. | Week 4 post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological Cure and Treatment Effectiveness | Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4. | Week 4 (two weeks post-treatment) |
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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.
Atopic or contact dermatitis.
Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
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 | ||
| University Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21968664 | Result | Parish LC, Parish JL, Routh HB, Avakian E, Olayinka B, Pappert EJ, Plaum S, Fleischer AB, Hardas B. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. J Drugs Dermatol. 2011 Oct;10(10):1142-7. |
| Label | URL |
|---|---|
| Naftin Cream 2% product information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAFT-500 | Naftin 2% cream applied daily for 2 weeks |
| FG001 | Placebo-2wks | Placebo cream applied daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo cream applied for up to 4 weeks |
|
| San Diego |
| California |
| 92123 |
| 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 |
| Tulane Univeristy Health Services Ctr. | 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 |
| Paddington Testing Company | Philadelphia | Pennsylvania | 19103 | United States |
| Tennesse Clinical Research | Nashville | Tennessee | 37215 | 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 |
| Oakwell Clinical Research | San Antonio | Texas | 78218 | United States |
| Edwin Camilio Vazquez, MD | Aguas Buenas | 00703 | Puerto Rico |
| Medicina General y Cirugia Menor | Cayey | 00736 | Puerto Rico |
| Advanced Medical Concepts, PSC | Cidra | 00739 | Puerto Rico |
| Manuel Guzman, MD | Humacao | 00791 | Puerto Rico |
| Isabel Quijano, MD | Rio Piedras | 00921 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NAFT-500 | Naftin 2% cream applied daily for 2 weeks |
| BG001 | Placebo-2wks | Placebo cream applied daily for 2 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done. | The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment. | Posted | Number | percentage of subjects with complete cur | Week 4 post-baseline |
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| Secondary | Mycological Cure and Treatment Effectiveness | Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4. | This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was 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 | Week 4 (two weeks post-treatment) |
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|
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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 | 166 | 4 | 166 | ||
| EG001 | Placebo-2wks | Placebo cream applied daily for 2 weeks | 0 | 168 | 10 | 168 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyslipidaemia | Metabolism and nutrition disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Headache | Nervous system disorders |
|
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 | |
|---|---|---|---|---|
| Merz Pharmaceuticals, LLC | Merz Pharmaceuticals, LLC | 800-334-0514 |
| ID | Term |
|---|---|
| D000084002 | Tinea Cruris |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| >=65 years |
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| Male |
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| Puerto Rico |
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