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To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Cream | Placebo Comparator | Topically applied once daily |
|
| Naftin 1% Cream | Experimental | Topically applied once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftin 1% Cream | Drug | Topically applied once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). | - Summarization of AEs (local and systemic) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH and culture positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). | Complete Cure based on: -Negative mycology results; absence (Grade 0) of erythema, scaling, and pruritis Other efficacy variables assessed at Week 2, Week 4, and 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.- Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
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 for at least 2 years are not considered to be of childbearing potential).
Subjects using the following medications:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Plaum, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site # 501001 | Belize City | Belize | ||||
| Merz Investigational Site # 501002 |
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| ID | Term |
|---|---|
| D000084002 | Tinea Cruris |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C029178 | naftifine |
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| Placebo Cream |
| Drug |
Topically applied once a day |
|
| Week 6 |
| Belize City |
| Belize |
| Merz Investigative Site # 180002 | San Cristobal | Dominican Republic |
| Merz Investigative Site # 180001 | Santo Domingo | Dominican Republic |
| Merz Investigative Site # 504001 | San Pedro Sula | Honduras |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |