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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Topically applied once a day
Topically applied once a day
Merz Investigational Site # 501001
Belize City, Belize
Merz Investigational Site # 501002
Belize City, Belize
Merz Investigative Site # 180002
San Cristóbal, Dominican Republic
Merz Investigative Site # 180001
Santo Domingo, Dominican Republic
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)
Time frame: Week 6
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
Time frame: Week 6
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Merz Investigative Site # 504001
San Pedro Sula, Honduras