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The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftin Cream, 2% | Experimental | Once Daily |
|
| Placebo Cream | Placebo Comparator | Once Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftin Cream | Drug |
| ||
| Placebo Cream |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy | Complete cure defined by negative KOH result and negative dermatophyte culture | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy | Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms. | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at Days 14 and 21 | Defined as sign and symptom scores of 0 or 1 | Day 14 and Day 21 |
| Clinical cure at Days 14 and 21 | Defined as erythema, induration, and pruritus score of 0. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Fleischer, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site#001316 | Tucson | Arizona | 85712 | United States | ||
| Investigative Site# 0010320 |
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|
| Days 14 and 21 |
| Subject Satisfaction | Assessment on 5 point scale or category of improvement from baseline. | Days 14 and 21 |
| Complete Cure | Defined as negative mycology and abscence of signs/symptoms. | Day 14 |
| Treatment of Effectiveness | Defined as negative KOH, negative culture, and signs/symptoms. | Day 14 |
| Mycology Cure | Defined as negative KOH result and negative dermatophyte culture. | Day 14 |
| Encino |
| California |
| 91436 |
| United States |
| Merz Investigative Site#001313 | Fremont | California | 94538 | United States |
| Merz Investigative Site#001301 | San Diego | California | 92102 | United States |
| Merz Investigative Site#001312 | Miami | Florida | 33144 | United States |
| Merz Investigative Site#001311 | Miami | Florida | 33175 | United States |
| Merz Investigative Site #001310 | Miramar | Florida | 33027 | United States |
| Merz Investigative Site#001307 | Saint Joseph | Missouri | 64506 | United States |
| Merz Investigative Site#001309 | Omaha | Nebraska | 68114 | United States |
| Merz Investigative Site#001314 | Henderson | Nevada | 89074 | United States |
| Merz Investigative Site#001126 | Raleigh | North Carolina | 27612 | United States |
| Merz Investigative Site#001293 | Winston-Salem | North Carolina | 27104 | United States |
| Investigative Site# 0010319 | Gresham | Oregon | 97030 | United States |
| Merz Investigative Site#001097 | Nashville | Tennessee | 37215 | United States |
| Merz Investigative Site#180002 | San Cristobal | Dominican Republic |
| Merz Investigative Site# 180001 | Santo Domingo | Dominican Republic |
| Merz Investigative Site#504001 | San Pedro Sula | Honduras |
| Merz Investigative Site#507001 | Panama City | Panama |
| Merz Investigative Site#001279 | Cidra | 00739 | Puerto Rico |
| ID | Term |
|---|---|
| D014005 | Tinea |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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