Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis.
BACKGROUND
Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects.<br/>


OBJECTIVE
To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.<br/>


METHODS
At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 3 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 231 subjects (n=116, naftifine; n=115, vehicle).<br/>


RESULTS
Children with tinea corporis treated with naftifine cream 2% demonstrated significantly greater improvements from baseline over vehicle for mycological cure (<em>P</em>&lt;0.0001) and treatment effectiveness (<em>P</em>=0.003) as early as 2 weeks (end of treatment). Response rates continued to increase post-treatment and were the highest 1-week after completion of the therapy (<em>P</em>=0.003 for complete cure; and <em>P</em>&lt;0.001 for mycological cure and treatment effectiveness). Treatment related adverse events were minimal.<br/>


CONCLUSIONS
Treatment with naftifine cream 2% applied once daily for two weeks was well-tolerated and was effective in treating tinea corporis in children. Further improvement was observed 1-week after treatment completion for all key outcome measures (complete cure, mycological cure, treatment effectiveness, clinical cure, and clinical success) and clinical signs and symptoms (erythema, induration, and pruritus). <br /><br /> <em>J Drugs Dermatol. </em>2016;15(6):743-748.
Michael
M
Gold
Sunil
S
Dhawan
Amit
A
Verma
Michael
M
Kuligowski
David
D
Dobrowski
D000279:Administration, Cutaneous; D000293:Adolescent; D000499:Allylamine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D009304:Nasopharyngitis / Q000139:chemically induced; D063465:Skin Cream / Q000008:administration & dosage* / Q000009:adverse effects; D014005:Tinea / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000499:Allylamine; C029178:naftifine