Naftifine hydrochloride gel 2% is effective as a topical therapy for moccasin-type tinea pedis

Naftifine hydrochloride gel 2% is effective as a topical therapy for moccasin-type tinea pedis

P6092 P6671 Lobomycosis: A case with multiple lesions Francisca Regina Oliveira Carneiro, MD, PhD, State Univeristy of Para, Belem, British Indian...

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P6092

P6671

Lobomycosis: A case with multiple lesions Francisca Regina Oliveira Carneiro, MD, PhD, State Univeristy of Para, Belem, British Indian Ocean Territory; Natasha Ferreira Santos Cruz, State University of Para, Belem, Brazil Jorge Lobo’s disease or lobomycosis is a tropical disease caused by a fungus which had received many nominations and actually the most accept is Lacazia loboi. Usually patients are male, agricultural workers, which probably were infected by local traumas with vegetables. Many types’ lesions can be observed included papules, nodules and infiltrated lesions and the most frequent site is limb. No systemic symptoms were observed and treatment is very difficult because most of patient has a poor response to usual therapies. The authors describe a male, 35years-old with nodules and papules isolated and confluent observed in the upper thigh since five years later, with no symptoms. The diagnosis was confirmed by skin direct microscopy which demonstrated multiples round structures in chains. Itraconazole associated with clofazimine was introduced with poor response.

Naftifine hydrochloride gel 2% is effective as a topical therapy for moccasin-type tinea pedis Stefan Plaum, MD, Merz Pharmaceuticals, Greensboro, NC, United States; Alan Fleischer, MD, Merz Pharmaceuticals, Greensboro, NC, United States; Amit Verma, PhD, Merz Pharmaceuticals, Greensboro, NC, United States; Babajide Olayinka, MS, Merz Pharmaceuticals, Greensboro, NC, United States; Bhushan Hardas, MD, Merz Pharmaceuticals, Greensboro, NC, United States Background: Naftifine hydrochloride (naftifine) is a topical antifungal of the allylamine class, displaying fungicidal and fungistatic activity. Naftifine is generally used to treat interdigital type tinea pedis; however, systemic therapy is often prescribed by health care providers for moccasin-type tinea pedis. Well-controlled clinical data on topical antifungal therapy for moccasin-type tinea pedis is limited. Objective: This randomized, vehicle-controlled study prospectively evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 2 and 4 weeks posttreatment in subjects with moccasin-type tinea pedis. Methods: At visit 1, subjects were randomized to naftifine gel 2% or vehicle groups and subjects underwent baseline mycology culture and symptom (erythema, scaling, and pruritus) severity grading. Naftifine gel 2% and vehicle treatment were applied once daily for 2 weeks and the subjects returned at weeks 2, 4, and 6 for efficacy evaluation (mycology culture and grading of symptom severity). Only subjects with positive baseline mycology culture and KOH with week 6 assessments were analyzed for efficacy (n ¼ 296, naftifine; n ¼ 150, vehicle). Mycologic cure is defined as a negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0.

Commercial support: None identified.

Results: At the end of treatment (week 2) pruritus significantly improved in the naftifine versus the vehicle group (P ¼ .02), and continued to improve at weeks 4 and 6 (P \.01). A significant improvement (P \.01) in erythema and scaling of $ 2 grades was seen in the naftifine arm versus the vehicle at weeks 4 and 6. At week 6, the mycologic cure rate, treatment effectiveness, and complete cure rate were significantly higher in the naftifine arm versus the vehicle (P \.0001). Treatment related AEs were minimal and the most common were application site pain, paraesthesia, and dermatitis. Conclusion: Two weeks application of topical naftifine gel 2% is an effective monotherapy treatment for moccasin-type tinea pedis. This research was funded by Merz Pharmaceuticals, LLC.

P6598 Metastatic chromoblastomycosis Rubicela Garza, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Cristina Cant u, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Fania Mu~ noz, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Irma Perez, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Jorge Ocampo, MD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico; Oliverio Welsh, MD, PhD, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Mexico Background: Chromoblastomycosis is a chronic skin and subcutaneous infection caused by dematiaceous fungi. These saprophytic fungi live in soil and plants of tropical regions. In Mexico it represents the third most common deep mycosis. Skin manifestations consist of nodules, plaques and verrucous lesions. Differential diagnoses include sporotrichosis, verrucous tuberculosis, coccidiodomycosis and sarcoidosis. It rarely causes disseminated disease; we present an uncommon case of metastatic Chromoblastomycosis. Case report: A 58-year-old Hispanic agriculturist male presented to the ER with a 40year history of a verrucous plaque in his buttocks that started after a puncture injury and progressed slowly in size. He complained of anorexia, vomiting, and weight loss. Before his admission, he developed subcutaneous chest tumors and an ulcerated plaque in his right knee. During examination he appeared physically ill. A 20 3 30 cm verrucous plaque involving hip and buttocks was observed. It consisted of exophytic and ulcerated lesions with foul-smelling secretion. No lymphadenopathy was noted. Another 6 3 6 cm hyperemic plaque was documented on his right knee. Two subcutaneous tumors were noted on his chest: one measuring 7 3 5 cm on the right supraclavicular region and the other 7 3 4 cm on his left chest wall. Both were soft, hyperemic and adhered to deep planes. Chest tomography showed a left parahiliar tumor and lytic lesions on his ribs. Hystopathologic examination of both plaques revealed epidermal pseudoepitheliomatous hyperplasia. A polymorphous cell infiltrate and circular, thick-walled, brown structures (Medlar bodies) within giant multinucleated cells were noted in the dermis; transbronchial biopsy and cytology of the chest subcutaneous tumors also reported these structures. Direct examination of all samples showed Medlar bodies and mycologic culture demonstrated growth of Fonsecaea pedrosoi. Therapy with oral itraconazole 400 mg/day was initiated after the diagnosis was confirmed; posterior improvement of skin lesions and systemic symptoms was noted.

P6646 Naftifine hydrochloride gel 2% is efficacious and safe for the treatment of tinea pedis: Results from a randomized, multicenter, double-blind, vehicle-controlled study Stefan Plaum, MD, Merz Pharmaceuticals, Greensboro, NC, United States; Alan Fleischer, MD, Merz Pharmaceuticals, Greensboro, NC, United States; Amit Verma, PhD, Merz Pharmaceuticals, Greensboro, NC, United States; Babajide Olayinka, MS, Merz Pharmaceuticals, Greensboro, NC, United States; Bhushan Hardas, MD, Merz Pharmaceuticals, Greensboro, NC, United States Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride (naftifine) is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant antibacterial and antiinflammatory effects. Objective: To evaluate the efficacy and safety of 2 weeks once daily application of naftifine gel 2% in the treatment of tinea pedis.

Conclusion: Chromoblastomycosis rarely presents in a disseminated form; however, there are few reported cases of extracutaneous hematogenous spread to lymph nodes, lungs or other tissues causing metastatic lesions. It is important to perform a mycologic and histopathologic study early during the course of the disease so antimycotic therapy can be initiated, lowering the morbidity and mortality of these infections.

Methods: At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel, 2% (n ¼ 1144) and vehicle (n ¼ 571). Naftifine gel, 2% and vehicle were applied once daily for 2 weeks. Efficacy was evaluated at baseline and at weeks 2, 4, and 6 and consisted of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity (erythema, scaling, pruritus) by a blinded evaluator. Efficacy was analyzed in 1174 subjects (n ¼ 782, naftifine; n ¼ 392, vehicle) with a positive baseline dermatophyte culture and KOH and for whom week 6 assessments were available. Safety was evaluated in 1714 subjects. Mycologic cure is defined as negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0. Results: At the end of treatment (week 2) pruritus significantly improved ( $ 2 grades) in the active vs the vehicle group (P ¼ .001), and continued to improve at weeks 4 and 6 (P \.0001). Erythema and scaling significantly improved $ 2 grades in the active arm versus the vehicle at weeks 4 and 6 (P \.0001). At weeks 2 and 6 the mycologic cure rate, treatment effectiveness, and complete cure rate were significantly higher in the active arm versus vehicle (P \.01). Treatment-related AEs occurred in 1.8% of naftifine subjects and 0.7% of vehicle subjects. The most common treatment related AEs were application site pain, paraesthesia, and dermatitis. Conclusion: Once daily naftifine gel 2% for 2 weeks is well tolerated and is effective in treating tinea pedis.

Commercial support: None identified.

This research was funded by Merz Pharmaceuticals, LLC.

APRIL 2013

J AM ACAD DERMATOL

AB129