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Clinical benefit and assessment of pharmacokinetic profile of naftifine hydrochloride gel 2%: An open-label, multicenter, multiple-application study in pediatric subjects with tinea pedis Amit Verma, PhD, MPH, Merz North America, Inc, Greensboro, NC, United States; Babajide Olayinka, MS, Merz North America, Inc, Greensboro, NC, United States; Alan Fleischer, MD, Merz North America, Inc, Greensboro, NC, United States Background: Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and antiinflammatory effects. Clinical data on topical antifungal therapy using naftifine for tinea pedis in a pediatric population is limited.
Cutaneous Paecilomyces lilacinus infection mimicking cellulitis in an immunocompetent patient Yen-Ta Chen, MD, Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan; Chih-Chiang Chen, MD, PhD, Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan; Han-Nan Liu, MD, Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan
Objective: To assess trends in efficacy, tolerability, safety, and to quantify the pharmacokinetics (PK) of topical naftifine hydrochloride gel 2% (NG2%) in pediatric subjects aged 12 to 17 years, 11 months with tinea pedis under maximal clinical use conditions (both feet affected). Methods: Twenty-two subjects were treated with NG2% once daily for two weeks and stayed at the study center on day 1 (first application) and day 14 (last application). Approximately 2 g of NG2% was applied to each foot (4 g total). Efficacy was assessed based on potassium hydroxide, dermatophyte culture, and signs and symptom results at days 7, 14 and 28. Efficacy analyses were performed using descriptive statistics. Adverse event information was collected routinely. PK blood samples were collected on days 1 and 14 for 24 hours: at 0 hour (preapplication); and 1, 2, 4, 6, 8, 12, and 24 hours postapplication. Preapplication (trough) samples were collected on days 1, 2, 7, 12, 13, and 14. Samples from days 12 through 14 were used to assess steady state. Additionally, samples were collected on days 21 (one week after the last application) and 28 (two weeks after the last application). Pharmacokinetic urine samples were obtained on days 1 and 14 before and after application for 24 hours. Results: Positive results were observed as early as day 7; however the proportion of subjects achieving success increased over time through day 28. Efficacy rates at day 28 were as follows: complete cure (27.3%), effective treatment (54.5%), mycologic cure (63.6%), clinical success (81.8%), and clinical cure (40.9%). PK results indicate that the rate and extent of systemic exposure was low. Adverse events were minimal and were not related to treatment. All adverse events resolved by the end of the study. Conclusions: NG 2% was found to be well tolerated and safe. Trends in clinical benefit were observed throughout the treatment period; however, continued improvement in efficacy rates were observed during the posttreatment period.
Introduction: Paecilomyces-related infection is a rare but emerging hyalohyphomycosis, mostly reported in the immunocompromised patients. Among the clinical manifestations of the fungal infection, cutaneous and subcutaneous infection is the second most common type, following oculomycosis. Colonization of clinical materials, such as catheters and implant, and direct inoculation are assumed as the main route of infection. Herein, we present an unusual cutaneous infection of Paecilomyces lilacinus in an elder but immunocompetent patient. Case report: An 87-year-old male, without immunocompromised status, presented with a 2-week history of a large expanding tender erythematous plaque on the right forearm (Fig 1, A). Before the skin lesion developed, he alleged that there were some itchy rashes over the same area and severe scratching with excoriation wound was noted by his family. Under the initial impression of cellulitis, intravenous oxacillin was used. Owing to the unresponsiveness to the treatment for one week, skin biopsy and tissue culture were then performed. The histopathology of the skin tissue revealed suppurative granulomas with positive PAS-D stain which showed nonpigmented septated branching hyphae (Fig 1, C and D). P lilacinus was further identified through the plate culture, morphologic identification, PCR and DNA sequencing. (Figs 1, D, and 2, A and B). Oral itraconazole 200 mg/day was subsequently initiated and his skin condition improved gradually after 4-week treatment (Fig 1, B). Discussion and conclusion: P lilacinus is a ubiquitous fungus found in the environment and becomes an emerging pathogen that infects mainly immunocompromised patients. Nonetheless, whenever a physician encounters cellulitis-like lesions with poor response to empiric antibiotics treatment, further evaluations including the survey of deep fungal infection are recommended even if the patient is immunocompetent. Commercial support: None identified.
This research was Sponsored by Merz North America, Inc
1499 Cold subcutaneous abscesses as the first manifestation of Coccidioides immitis infection in an immunocompromised host Juana Irma Garza-Chapa, MD, Hospital Universitario ‘‘Dr Jose Eleuterio Gonzalez,’’ Monterrey, Mexico; Sylvia Aide Martınez-Cabriales, MD, Hospital Universitario ‘‘Dr Jos e Eleuterio Gonzalez,’’ Monterrey, Mexico; Minerva G omez-Flores, MD, Hospital Universitario ‘‘Dr Jose Eleuterio Gonzalez,’’ Monterrey, Mexico; Jorge Ocampo-Candiani, MD, Hospital Universitario ‘‘Dr Jose Eleuterio Gonzalez,’’ Monterrey, Mexico; Oliverio Welsh, MD, PhD, Hospital Universitario ‘‘Dr Jose Eleuterio Gonzalez,’’ Monterrey, Mexico A 35-year-old man with a past history of systemic lupus erythematous, antiphospholipid syndrome, and pulmonary thromboembolism treated for the past 8 months with methotrexate, prednisone, hydroxychloroquine and warfarin was referred to dermatology because of several skin nodules. Two months before he referred a left groin subcutaneous mass that drained spontaneously. During the next 6 weeks, several cold nonerythematous abscesses appeared on his back. Two were drained by a surgeon without taking cultures. When first seen in dermatology, the patient presented two firm nonpainful subcutaneous nodules without erythema that when the biopsy was taken, drained pus; cultures for bacteria and fungi were obtained. He denied any systemic symptoms. Lupus panniculitis, typical and atypical mycobacterial infections and systemic mycosis were considered in the differential diagnosis. Laboratory findings included leukocytosis with neutrophilia and a normal ESR. Two days later, the patient developed dyspnea, pleuritic pain, cough and fever. A chest radiograph revealed pleural effusion and CT showed a micronodular infiltrate. The skin biopsy revealed granulomatous inflammation and the presence of Coccidioides immitis spherules. Fungus culture confirmed the diagnosis. Prednisone was tapered and methotrexate was stopped. Itraconazole 400 mg daily was administrated and resolution of all cold abscesses and pulmonary symptoms occurred in the following 8 weeks. Primary inoculation of C immitis is generally through the lung and it is usually asymptomatic or with minimal-moderate flu-like symptoms. In 5% to 10% of symptomatic patients, coccidioidomycosis can affect other organs such as skin, bone, joints and CNS. The risk of dissemination is increased in immunocompromised patients. Identification of the fungus is essential for prompt and successful antifungal therapy. Cutaneous lesions can be the first manifestations of this infection; they can appear in the form of papules, nodules, verrucous plaques, pustules, ulcers, scars, fistulae and erythematous abscesses. Cold abscesses should also be included in the clinical spectrum of this fungal disease. Commercial support: None identified.
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J AM ACAD DERMATOL
1416 Cutaneous sporotrichosis: Fixed and lymphangitic Michelle De Arbeloa, MD, Instituto de Biomedicina ‘‘Dr Jacinto Convit,’’ Caracas, Venezuela Sporotrichosis is a subcutaneous infection with worldwide distribution, although it is more frequent in tropical countries. We report two cases of sporotrichosis. The first case, is a 70-year-old female farmer with fixed cutaneous sporotrichosis, who began illness in August 2012 characterized by numerous erythematous and pruritic papules on dorsum of the right hand, which converge to scaly plaques, with crusts and erosions in the surface. Sporotrichin test was positive (55 3 67 mm), biopsy report nodular and diffuse dermatitis compatible with granuloma induced by living agent; S schenkii complex was isolated in Sabouraud agar culture. Second case, is a 60-year-old male baseball trainer with lymphangitic cutaneous sporotrichosis, who began illness in 2013 with erythematous scaly plaques in right forearm with lymphangitic distribution nodules, thought the arm. Sporotrichin test was positive (14 3 15 mm). S schenkii complex was isolated in Sabouraud agar culture and biopsy conclude granuloma induced by living agent. Both patients were treated with 3 g daily of saturated solution of potassium iodine (SSKI) during two months with satisfactory evolution. Discussion: Venezuela as other Latin American countries have a high prevalence of sporotrichosis (0.1-0.5%). Most of the lesions are localized in skin and subcutaneous tissues and are inoculated during outdoor activities. It has been proposed that immunologic status and temperature influences the clinical course of the disease. There are many therapeutic options; however, SSKI is considered the criterion standard in developing countries because of low cost, effectiveness and safety. Commercial support: None identified.
MAY 2015