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Scedosporium apiospermum skin infection successfully treated with voriconazole
P2407
P2409
A case of cutaneous mucormycosis mimicking sporotrichosis Jong Suk Lee, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Cheonan-si, South Korea; Kyu Uang Whang, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Seoul, South Korea; Sung Yul Lee, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Cheonan-si, South Korea; Young Lip Park, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Bucheon-si, South Korea Mucormycosis is a rare invasive fungal infection chiefly occurring in immunocompromised patients and resulting in a fatal outcome. As increased patients that have immunocompromised and metabolic disorders, incidence of mucormycosis attracts attentions. Primary cutaneous mucormycosis is a rare phenotype of mucormycosis, usually follows direct inoculation of fungi on damaged skin. Many cutaneous infections mimick sprotrichosis including virus, bacteria, acid-fast bacilli, fungi, and protozoa; however, mucormycosis is very rare. Mucormycosis is treated by extensive excision and systemic antifungals, especially high dose of amphotericin B. A 77year-old woman presented with painful crusted and ulcerated erythematous plaques on her left wrist and forearm. These skin lesions are improved and worsened repetitively. Histopathologic examination revealed extensive inflammatory infiltration and granulomatous reaction with multinucleated giant cells on dermis and broad, aseptated hypae in intercellular space, more visible on PAS staining. On fungal culture study, sporangium is detected in terminal of sporangiophore on microscopy. Herein we report a case of cutaneous mucormycosis mimicking sporotrichosis in a 77-ye ar-old woman.
A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream, naftifine hydrochloride 1% cream, and placebo in tinea pedis Lawrence Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, Greensboro, NC, United States; Hirak Routh, Parish Dermatology, Philadelphia, PA, United States; Jennifer Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Mandeep Kaur, MD, Merz Pharmaceuticals, Greensboro, NC, United States
Commercial support: None identified.
Results: NAFT-500 versus PBO: 353 subjects were randomized (235 NAFT-500 and 118 PBO). Two hundred seventeen of 353 (61.5%) had a positive culture at baseline (147 NAFT-500 and 70 PBO). For those subjects with a positive culture at baseline, at weeks 2 and 4 there were no differences between the two groups in terms of complete cure; however, at week 6, NAFT-500 was superior to PBO (17.7% vs 7.1%; P ¼ .01). At week 2, there was no difference between the two groups in terms of mycologic cure (P ¼ .098) or treatment effectiveness (P ¼ .92). At weeks 4 and 6 there was a statistically significant advantage in favor of NAFT-500 over PBO in mycologic cure (P \.001) and treatment effectiveness (P \.001). Twenty AEs were considered treatment-related (12/235 NAFT-500 and 8/118 PBO). NAFT-1 versus PBO: 356 subjects were randomized (237 NAFT-1 and 119 PBO). Two hundred eight of 356 had a positive culture at baseline (143 NAFT-1 and 65 PBO). For those subjects with a positive culture at baseline, the complete cure, mycologic cure, and treatment effectiveness results were similar to those seen with NAFT-500. Nineteen AEs were considered treatment-related (9/237 NAFT-1 and 10/119 PBO). Conclusions: In this study, both NAFT-1 QD 3 4 weeks and NAFT-500 QD 3 2 weeks were well-tolerated and were both statistically superior to PBO for the treatment of tinea pedis.
P2408
Commercial support: Merz Pharmaceuticals.
Background: Naftifine hydrochloride 1% cream (NAFT-1) is a FDA-approved topical antifungal. Naftifine hydrochloride 2% cream (NAFT-500) is under development in the United States. Objective: To assess the efficacy and safety of NAFT-500 compared to placebo (PBO) and NAFT-1 compared to PBO in the treatment of tinea pedis. Methods: This was a double-blind, double PBO-controlled study comparing NAFT500 applied daily (QD) for 2 weeks and PBO and NAFT-1 applied QD for 4 weeks and PBO. Subjects were evaluated at weeks 2, 4, and 6 for efficacy which was complete cure (negative mycology [KOH and culture] and negative signs and symptoms [absence of erythema, scaling and pruritus], mycologic cure [negative KOH and culture], and treatment effectiveness [negative KOH, negative culture and erythema, scaling and pruritus grades of 0 and 1]). The analyses of the key efficacy endpoints were carried out using the one-sided CMH test at the 2.5% level of significance, after stratifying by investigational site to determine superiority of NAFT500 over PBO only on subjects who had positive culture results at baseline. Adverse events (AEs) were summarized using counts and percentages.
A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream and placebo applied daily for 2 weeks in patients with tinea cruris Larence Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, Greensboro, NC, United States; Hirak Routh, Parish Dermatology, Philadelphia, PA, United States; Jennifer Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Mandeep Kaur, MD, Merz Pharmaceuticals, Greensboro, NC, United States Background: Naftifine hydrochloride 2% cream (NAFT-500) is a topical antifungal preparation under development in the United States. Objective: To assess the efficacy and safety of NAFT-500 compared to placebo (PBO) in the treatment of tinea cruris. Methods: This was a double-blind study comparing NAFT-500 applied daily (QD) for 2 weeks with PBO. Subjects were evaluated at weeks 2 and 4 for complete cure (negative mycology [KOH and culture] and negative signs and symptoms [absence of erythema, scaling, and pruritus], mycologic cure [negative KOH and culture], and treatment effectiveness [negative KOH, negative culture and erythema, scaling and pruritus grades of 0 and 1]). Efficacy (superiority) in terms of complete cure, treatment effectiveness, and mycologic cure of NAFT-500 over PBO was assessed only among subjects who had positive culture results at baseline by using the CMH method after stratifying by site at a one-sided level of significance of 2.5%. Adverse events (AEs) were summarized descriptively using counts and percentages.
P2410 Scedosporium apiospermum skin infection successfully treated with voriconazole Lizbeth Ruth Aragones Intong, MD, St. George Hospital Department of Dermatology, Sydney, New South Wales, Australia; Dedee Murrell, MD, St. George Hospital Department of Dermatology, Sydney, New South Wales, Australia; Kenneth Ho, MBBS, Royal Prince Alfred Hospital Department of Dermatology, Sydney, New South Wales, Australia; Pamela Konecny, MD, MBBS, St. George Hospital Department of Immunology, Allergy and Infectious Disease, Sydney, New South Wales, Australia; Vanita Bhargava, MBBS, St. George Hospital Department of Anatomical Pathology, Sydney, New South Wales, Australia
Results: Three hundred thirty-four subjects were randomized (166 NAFT-500 and 168 PBO). On hundred forty-six out of 334 (43.7%) had a positive culture at baseline (74 NAFT-500 and 72 PBO). Two hundred eighty-five of 334 (85.3%) completed the study (144 NAFT-500 and 141 PBO). Two hundred eighty-two of 334 (84.4%) were male with a mean age of 46.7 years. Superiority of NAFT-500 over PBO (25.3% vs 2.8% respectively at week 4, 2 weeks after completed treatment; P \.001) in terms of complete cure was obtained. At week 4, there was also a statistically significant advantage for NAFT-500 over PBO in terms of mycologic cure (72% vs 15.5%, respectively; P\.001) and treatment effectiveness (60.0% vs 9.9%; respectively; P \ .001). At week 4, clinical cure, assessed using the Physician’s Global Evaluation, was achieved by 39.1% of subjects in the NAFT-500 group and 12.7% of subjects in the PBO group. At week 4, a higher percentage of subjects in the NAFT-500 group showed excellent or much improvement (73.3%) compared with 28.2% in the PBO group as assessed by the subject satisfaction assessment. There were 11 AEs considered related to treatment during the study (7 NAFT-500 and 4 PBO) and the most common were contact dermatitis (2 NAFT-500), pruritus (2 PBO), and application site reaction (1 subject in each group). Conclusion: In this study, NAFT-500 applied QD 3 2 weeks was well-tolerated and statistically superior to PBO for the treatment of tinea cruris.
An 89-year-old white man with multiple underlying medical conditions presented with an indurated erythematous plaque on his left arm that had been enlarging over the past few months. This started from a small scratch on his arm while gardening. It was initially treated as sporotrichosis because of the presence of septate branching hyphae in the initial biopsy specimen. He was started on supersaturated solution of potassium iodide without any improvement. Because of progression, another biopsy speicmen was taken for hematoxylineeosin staining and fungal and mycobacterial cultures. Suppurative granulomas were demonstrated on hematoxylineeosin stain. PAS and Grocott methenamine silver stains also demonstrated septate branching fungal hyphae within the dermal suppurative granulomas. Other special stains (Gram, ZiehleNeelsen, WadeeFite, and WarthineStarry) were all negative. Scedosporium apiospermum, a common soil fungus, was isolated from culture and confirmed with molecular sequencing. The S apiospermum isolate was sensitive to voriconazole and posaconazole, and resistant to amphotericin B and caspofungin. The patient was treated with voriconazole for 6 months with progressive improvement. This particular fungal species is now increasingly recognised as a significant invasive pathogen, particularly in immunosuppressed patients. It is important to consider these fungal pathogens in the differential diagnoses of such lesions. It is also ideal to send tissue for culture and molecular sequencing for identification of species and antifungal susceptibility, which may be very limited.
Commercial support: Merz Pharmaceuticals.
Commercial support: None identified.
AB104
J AM ACAD DERMATOL
FEBRUARY 2011
P2409
A case of cutaneous mucormycosis mimicking sporotrichosis Jong Suk Lee, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Cheonan-si, South Korea; Kyu Uang Whang, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Seoul, South Korea; Sung Yul Lee, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Cheonan-si, South Korea; Young Lip Park, MD, PhD, Department of Dermatology, College of Medicine, Soonchunhyang University, Bucheon-si, South Korea Mucormycosis is a rare invasive fungal infection chiefly occurring in immunocompromised patients and resulting in a fatal outcome. As increased patients that have immunocompromised and metabolic disorders, incidence of mucormycosis attracts attentions. Primary cutaneous mucormycosis is a rare phenotype of mucormycosis, usually follows direct inoculation of fungi on damaged skin. Many cutaneous infections mimick sprotrichosis including virus, bacteria, acid-fast bacilli, fungi, and protozoa; however, mucormycosis is very rare. Mucormycosis is treated by extensive excision and systemic antifungals, especially high dose of amphotericin B. A 77year-old woman presented with painful crusted and ulcerated erythematous plaques on her left wrist and forearm. These skin lesions are improved and worsened repetitively. Histopathologic examination revealed extensive inflammatory infiltration and granulomatous reaction with multinucleated giant cells on dermis and broad, aseptated hypae in intercellular space, more visible on PAS staining. On fungal culture study, sporangium is detected in terminal of sporangiophore on microscopy. Herein we report a case of cutaneous mucormycosis mimicking sporotrichosis in a 77-ye ar-old woman.
A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream, naftifine hydrochloride 1% cream, and placebo in tinea pedis Lawrence Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, Greensboro, NC, United States; Hirak Routh, Parish Dermatology, Philadelphia, PA, United States; Jennifer Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Mandeep Kaur, MD, Merz Pharmaceuticals, Greensboro, NC, United States
Commercial support: None identified.
Results: NAFT-500 versus PBO: 353 subjects were randomized (235 NAFT-500 and 118 PBO). Two hundred seventeen of 353 (61.5%) had a positive culture at baseline (147 NAFT-500 and 70 PBO). For those subjects with a positive culture at baseline, at weeks 2 and 4 there were no differences between the two groups in terms of complete cure; however, at week 6, NAFT-500 was superior to PBO (17.7% vs 7.1%; P ¼ .01). At week 2, there was no difference between the two groups in terms of mycologic cure (P ¼ .098) or treatment effectiveness (P ¼ .92). At weeks 4 and 6 there was a statistically significant advantage in favor of NAFT-500 over PBO in mycologic cure (P \.001) and treatment effectiveness (P \.001). Twenty AEs were considered treatment-related (12/235 NAFT-500 and 8/118 PBO). NAFT-1 versus PBO: 356 subjects were randomized (237 NAFT-1 and 119 PBO). Two hundred eight of 356 had a positive culture at baseline (143 NAFT-1 and 65 PBO). For those subjects with a positive culture at baseline, the complete cure, mycologic cure, and treatment effectiveness results were similar to those seen with NAFT-500. Nineteen AEs were considered treatment-related (9/237 NAFT-1 and 10/119 PBO). Conclusions: In this study, both NAFT-1 QD 3 4 weeks and NAFT-500 QD 3 2 weeks were well-tolerated and were both statistically superior to PBO for the treatment of tinea pedis.
P2408
Commercial support: Merz Pharmaceuticals.
Background: Naftifine hydrochloride 1% cream (NAFT-1) is a FDA-approved topical antifungal. Naftifine hydrochloride 2% cream (NAFT-500) is under development in the United States. Objective: To assess the efficacy and safety of NAFT-500 compared to placebo (PBO) and NAFT-1 compared to PBO in the treatment of tinea pedis. Methods: This was a double-blind, double PBO-controlled study comparing NAFT500 applied daily (QD) for 2 weeks and PBO and NAFT-1 applied QD for 4 weeks and PBO. Subjects were evaluated at weeks 2, 4, and 6 for efficacy which was complete cure (negative mycology [KOH and culture] and negative signs and symptoms [absence of erythema, scaling and pruritus], mycologic cure [negative KOH and culture], and treatment effectiveness [negative KOH, negative culture and erythema, scaling and pruritus grades of 0 and 1]). The analyses of the key efficacy endpoints were carried out using the one-sided CMH test at the 2.5% level of significance, after stratifying by investigational site to determine superiority of NAFT500 over PBO only on subjects who had positive culture results at baseline. Adverse events (AEs) were summarized using counts and percentages.
A double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of naftifine hydrochloride 2% cream and placebo applied daily for 2 weeks in patients with tinea cruris Larence Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, Greensboro, NC, United States; Hirak Routh, Parish Dermatology, Philadelphia, PA, United States; Jennifer Parish, MD, Parish Dermatology, Philadelphia, PA, United States; Mandeep Kaur, MD, Merz Pharmaceuticals, Greensboro, NC, United States Background: Naftifine hydrochloride 2% cream (NAFT-500) is a topical antifungal preparation under development in the United States. Objective: To assess the efficacy and safety of NAFT-500 compared to placebo (PBO) in the treatment of tinea cruris. Methods: This was a double-blind study comparing NAFT-500 applied daily (QD) for 2 weeks with PBO. Subjects were evaluated at weeks 2 and 4 for complete cure (negative mycology [KOH and culture] and negative signs and symptoms [absence of erythema, scaling, and pruritus], mycologic cure [negative KOH and culture], and treatment effectiveness [negative KOH, negative culture and erythema, scaling and pruritus grades of 0 and 1]). Efficacy (superiority) in terms of complete cure, treatment effectiveness, and mycologic cure of NAFT-500 over PBO was assessed only among subjects who had positive culture results at baseline by using the CMH method after stratifying by site at a one-sided level of significance of 2.5%. Adverse events (AEs) were summarized descriptively using counts and percentages.
P2410 Scedosporium apiospermum skin infection successfully treated with voriconazole Lizbeth Ruth Aragones Intong, MD, St. George Hospital Department of Dermatology, Sydney, New South Wales, Australia; Dedee Murrell, MD, St. George Hospital Department of Dermatology, Sydney, New South Wales, Australia; Kenneth Ho, MBBS, Royal Prince Alfred Hospital Department of Dermatology, Sydney, New South Wales, Australia; Pamela Konecny, MD, MBBS, St. George Hospital Department of Immunology, Allergy and Infectious Disease, Sydney, New South Wales, Australia; Vanita Bhargava, MBBS, St. George Hospital Department of Anatomical Pathology, Sydney, New South Wales, Australia
Results: Three hundred thirty-four subjects were randomized (166 NAFT-500 and 168 PBO). On hundred forty-six out of 334 (43.7%) had a positive culture at baseline (74 NAFT-500 and 72 PBO). Two hundred eighty-five of 334 (85.3%) completed the study (144 NAFT-500 and 141 PBO). Two hundred eighty-two of 334 (84.4%) were male with a mean age of 46.7 years. Superiority of NAFT-500 over PBO (25.3% vs 2.8% respectively at week 4, 2 weeks after completed treatment; P \.001) in terms of complete cure was obtained. At week 4, there was also a statistically significant advantage for NAFT-500 over PBO in terms of mycologic cure (72% vs 15.5%, respectively; P\.001) and treatment effectiveness (60.0% vs 9.9%; respectively; P \ .001). At week 4, clinical cure, assessed using the Physician’s Global Evaluation, was achieved by 39.1% of subjects in the NAFT-500 group and 12.7% of subjects in the PBO group. At week 4, a higher percentage of subjects in the NAFT-500 group showed excellent or much improvement (73.3%) compared with 28.2% in the PBO group as assessed by the subject satisfaction assessment. There were 11 AEs considered related to treatment during the study (7 NAFT-500 and 4 PBO) and the most common were contact dermatitis (2 NAFT-500), pruritus (2 PBO), and application site reaction (1 subject in each group). Conclusion: In this study, NAFT-500 applied QD 3 2 weeks was well-tolerated and statistically superior to PBO for the treatment of tinea cruris.
An 89-year-old white man with multiple underlying medical conditions presented with an indurated erythematous plaque on his left arm that had been enlarging over the past few months. This started from a small scratch on his arm while gardening. It was initially treated as sporotrichosis because of the presence of septate branching hyphae in the initial biopsy specimen. He was started on supersaturated solution of potassium iodide without any improvement. Because of progression, another biopsy speicmen was taken for hematoxylineeosin staining and fungal and mycobacterial cultures. Suppurative granulomas were demonstrated on hematoxylineeosin stain. PAS and Grocott methenamine silver stains also demonstrated septate branching fungal hyphae within the dermal suppurative granulomas. Other special stains (Gram, ZiehleNeelsen, WadeeFite, and WarthineStarry) were all negative. Scedosporium apiospermum, a common soil fungus, was isolated from culture and confirmed with molecular sequencing. The S apiospermum isolate was sensitive to voriconazole and posaconazole, and resistant to amphotericin B and caspofungin. The patient was treated with voriconazole for 6 months with progressive improvement. This particular fungal species is now increasingly recognised as a significant invasive pathogen, particularly in immunosuppressed patients. It is important to consider these fungal pathogens in the differential diagnoses of such lesions. It is also ideal to send tissue for culture and molecular sequencing for identification of species and antifungal susceptibility, which may be very limited.
Commercial support: Merz Pharmaceuticals.
Commercial support: None identified.
AB104
J AM ACAD DERMATOL
FEBRUARY 2011