Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris

Conditions
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Tinea Cruris, Jock Itch

Intervention / Treatment
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* Drug: Naftin 1% Cream
* Drug: Placebo Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Review and sign statement of Informed Consent and HIPAA authorization. Males or non-pregnant females ≥ 12 years of age to 17 years, 11 months, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test. The parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate). Presence of tinea cruris characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms. KOH positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity. Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations. Subject must be able to understand the requirements of the study and willing to comply with the study requirements. 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: Topical anti-fungal therapy, powders or topical corticosteroids applied within 14 days prior to randomization. Terbinafine, butenafine, and naftifine (topical) within 30 days prior to randomization. Oral anti-fungal therapies within 3 months of randomization (8 months for oral terbinafine). Systemic antibiotic or corticosteroid treatment within 30 days of randomization. Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Cream<br>Topically applied once daily | Drug: Placebo Cream<br>* Topically applied once a day<br>|
| Experimental: Naftin 1% Cream<br>Topically applied once daily | Drug: Naftin 1% Cream<br>* Topically applied once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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: Effective treatment Mycological cure Clinical Success Clinical Cure Investigator Global Assessment Subject Satisfaction Assessment | Week 6 |