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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During clinical trials, 760 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 421 subjects with interdigital tinea pedis and/or tinea cruris were treated with NAFTIN Cream.
In two randomized, vehicle-controlled trials (400 patients were treated with NAFTIN Cream). The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin. In the two vehicle-controlled trials, 17.5% of NAFTIN Cream treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction ( ≥ 1%) is pruritus. Most adverse reactions were mild in severity. The incidence of Adverse Reactions in the NAFTIN Cream treated population were not significantly different than the vehicle treated population.
In an open-label pediatric pharmacokinetics and safety trial, 22 pediatric subjects 13-17 years of age with interdigital tinea pedis and tinea cruris received NAFTIN Cream. The incidence of adverse reactions in the pediatric population was similar to that observed in the adult population.
The following adverse reactions have been identified during post-approval use of (naftifine hydrochloride): redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the Naftin Cream (naftifine hcl) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/2/2014
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