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A pilot, double-blind, placebo-controlled study to assess the efficacy and safety of incobotulinumtoxinA injections in the treatment of rosacea
4873
5694
A phase 3 randomized, double-blind trial comparing the efficacy and safety of the fixed combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance Mark Lebwohl, MD, Department of Dermatology, Icahn School of Medicine at Mount Sinai; Linda Stein Gold, MD, Henry Ford Health System; Anja Snel, LEO Pharma A/S; Kristian Reich, Dermatologikum Hamburg Background: Psoriasis is a chronic inflammatory skin disease requiring long-term treatment for most patients. Topical maintenance treatment regimens consisting of a corticosteroid and a vitamin D analogue have shown to be effective and well tolerated. However, since these regimens require the use of multiple products on different days, which may be challenging for a patient in terms of adherence, a fixed combination treatment for maintenance of response would provide a convenient alternative. The calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) aerosol foam was developed to improve psoriasis treatment. The clinical efficacy and safety of this Cal/BD foam formulation has been documented in vehicleand active-comparator trials of 4 and 12 weeks’ duration.
A pilot, double-blind, placebo-controlled study to assess the efficacy and safety of incobotulinumtoxinA injections in the treatment of rosacea Steven Dayan, MD, DeNova Research; Nazanin Ashourian, PhD, DeNova Research; Katherine Cho, MPH, DeNova Research
Objectives and Trial Design: The present trial will evaluate the long-term efficacy and safety of a Cal/BD aerosol foam twice weekly maintenance regimen compared to vehicle in patients with mild-to-severe plaque psoriasis. During an initial 4-week, openlabel period, all patients will be treated once daily with Cal/BD aerosol foam. Patients who achieve treatment success (a Physician’s Global Assessment [PGA] score of ‘clear’ or ‘almost clear’ with at least a 2-step improvement) at Week 4 will be randomized to either active treatment or vehicle twice weekly (3 to 4 days apart) for up to 52 weeks. Relapses (PGA score of at least ‘mild’), will be treated with Cal/BD aerosol foam once daily for up to 4 weeks until clearance is achieved; then twice weekly maintenance regimen will be resumed. If clearance is not regained within 4 weeks, the patients will leave the trial. Thus, the trial will compare two ways of using Cal/BD aerosol foam: a proactive approach with fixed twice-weekly maintenance regimen versus a conventional, reactive approach. The primary endpoint is time to first relapse. A total of 380 patients will be randomized in the trial, which is recruiting at approximately 50 sites in 5 countries. It is planned to enrol the first patient in Q4 2016. The results from this trial will add significantly to our knowledge on maintenance treatment of plaque psoriasis. Important data on long-term safety and efficacy of Cal/BD aerosol foam will be generated to show the potential of a convenient, well-tolerated fixed combination treatment for the maintenance of remission.
Background: Although rosacea can have a variable presentation, erythema and flushing are consistently observed in most patients. The objective of this study was to evaluate the safety and efficacy of incobotulinumtoxinA in reducing the primary symptoms of rosacea. Methods: Subjects (N ¼ 9) with erythematotelangiectactic or papulopustular rosacea, were randomized to receive up to 20 U of incobotulinumtoxinA injected in the affected area on both cheeks (Group 1; n ¼ 4) or equal volumes of a saline solution (Group 2; n ¼ 5). Assessments at baseline and at 1, 4, 12, and 16 weeks posttreatment included Rosacea Clinical Scores (RCS) and subject satisfaction. At week 16, both groups received incobotulinumtoxinA injections in the affected areas in both cheeks. Assessments were performed at 1 and 4 weeks post-retreatment. Results: A reduction in the primary features of rosacea was observed among subjects in Group 1 within 4 weeks of treatment with incobotulinumtoxinA as assessed by RCS. Subjects in Group 2 did not demonstrate any improvement in the features of rosacea following the saline injection. After receiving incobotulinumtoxinA treatment at week 16, subjects in Group 2 exhibited reductions in all of the primary and some of the secondary features of rosacea upon treatment with incobotulinumtoxinA. Subject satisfaction was higher among those receiving incobotulinumtoxinA treatment compared with placebo following the initial injection. Subjects in Group 2 who received incobotulinumtoxinA at week 16 reported higher satisfaction following retreatment. Conclusions: IncobotulinumtoxinA may be a safe and effective method to reduce the severity of rosacea symptoms and increase patient satisfaction. Commercial support: This study was supported by Merz North America, Inc.
Commercial support: LEO Pharma A/S funded this study.
5045 A pilot study - Safety and efficacy of fermented olive tree leaf extracts for chronic paronychia and Neoscytalidium dimidiatum onychomycosis treatment Pattriya Chanyachailert, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Summanas Bunyaratavej, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Charussri Leeyaphan, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Waritch Kobwanthanakun, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Chuda Rujitharanawong, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Sutasinee Phaitoonwattanakij, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Kamonpan Lertrujiwanit, BS, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Introduction: Chronic paronychia and nondermatophyte onychomycosis are the common nail infections worldwide. Neoscytalidium dimidiatum is recognized as the recalcitrant organisms especially in tropical countries. Antifungal property in Olea europaea leaf extracts has been reported in vitro studies. Objective: Objective of this study was to evaluate efficacy and safety of O europaea leaf extraction for the treatment at 6 months. Methods: A pilot prospective study was conducted in patients with chronic paronychia and with nondermatophyte onychomycosis. O europaea leaf extracts were applied twice a day with self-mechanical reduction by nail emery. Chronic paronychia grading, normal nail length for non-dermatophyte onychomycosis, fungal microscopic examination, and fungal culture were recorded at first time visit, 2-, 4-, and 6-months after the treatment. Clinical and laboratory assessment by 2 dermatologists at each visit was compared to the first visit. Results: Nine female patients diagnosed as chronic paronychia were enrolled. Mean age (SD) was 60.1 ( 6 10.6) years. The affected sites were 7 thumbnails and 2 index finger nails. Mean severity grading was grade 3; ranged from grade 1-4. Culture revealed Candida albicans in all patients. Comparing with baseline at the first visit, severity of chronic paronychia was significantly reduced within 6 months after treating with O europaea leaf extracts (P ¼ .021). Complete cure for chronic paronychia was 56% at 6 months after treatment. For nondermatophyte onychomycosis, 6 male and 3 female patients were included. Mean age (SD) was 67.2 (6 7.9) years. All patients had N dimidiatum onychomycosis. Big toenails were affected in all patients. Mean normal nail length was 7.1 (6 1.2) mm. After treating with O europaea leaf extracts, mean normal nail toenail length at 4- and 6- month periods were 8.4 (6 0.8) and 8.9 (6 0.8) mm consequently, which demonstrated significant improvement when compared to mean normal nail length at first visit (P ¼ .047, P ¼ .016, respectively). Complete cure for nondermatophyte onychomycosis was 22% at 6 months after treatment, however, 78% had the clinical cure and 33% achieved mycological cure after 6-month treatment. No adverse event was observed in the study. Conclusion: O europaea leaf extracts could be an effective alternative topical treatment for chronic paronychia from C albicans infection and N dimidiatum onychomycosis. Commercial support: None identified.
JUNE 2017
4524 A population based cohort study of atopic dermatitis among young adult males in Singapore Wai Leong Kok, MBBS, Singapore Armed Forces; Yik Weng Yew, MBBS, National Skin Centre; Tien Guan Steven Thng, MBBS, National Skin Centre Background: Atopic dermatitis is a chronic relapsing condition with significant morbidity. There is a relative lack of data on the prevalence in the young adult age group in an urbanized, multicultural society such as Singapore. The objective of the study was to determine the period prevalence trends in a cohort of young adult males in Singapore over a five year period, as well as the demographic factors and coexisting medical conditions. Methods: A population based retrospective cohort study utilizing existing electronic medical records of baseline medical screening of young males conscripted into military service in Singapore over a five-year period was performed. Results: The period prevalence of atopic dermatitis among Singaporean male young adults was 9.76%, with a significant trend of increasing severity over the years. Moreover, increase in body mass index was associated with moderate or severe atopic dermatitis. Conclusion: The period prevalence of atopic dermatitis in young adults in Singapore is on a decreasing trend, albeit with a higher proportion of moderate or severe atopic dermatitis cases. Commercial support: None identified.
J AM ACAD DERMATOL
AB21
5694
A phase 3 randomized, double-blind trial comparing the efficacy and safety of the fixed combination calcipotriene 0.005% (Cal) and betamethasone dipropionate 0.064% (BD) aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance Mark Lebwohl, MD, Department of Dermatology, Icahn School of Medicine at Mount Sinai; Linda Stein Gold, MD, Henry Ford Health System; Anja Snel, LEO Pharma A/S; Kristian Reich, Dermatologikum Hamburg Background: Psoriasis is a chronic inflammatory skin disease requiring long-term treatment for most patients. Topical maintenance treatment regimens consisting of a corticosteroid and a vitamin D analogue have shown to be effective and well tolerated. However, since these regimens require the use of multiple products on different days, which may be challenging for a patient in terms of adherence, a fixed combination treatment for maintenance of response would provide a convenient alternative. The calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) aerosol foam was developed to improve psoriasis treatment. The clinical efficacy and safety of this Cal/BD foam formulation has been documented in vehicleand active-comparator trials of 4 and 12 weeks’ duration.
A pilot, double-blind, placebo-controlled study to assess the efficacy and safety of incobotulinumtoxinA injections in the treatment of rosacea Steven Dayan, MD, DeNova Research; Nazanin Ashourian, PhD, DeNova Research; Katherine Cho, MPH, DeNova Research
Objectives and Trial Design: The present trial will evaluate the long-term efficacy and safety of a Cal/BD aerosol foam twice weekly maintenance regimen compared to vehicle in patients with mild-to-severe plaque psoriasis. During an initial 4-week, openlabel period, all patients will be treated once daily with Cal/BD aerosol foam. Patients who achieve treatment success (a Physician’s Global Assessment [PGA] score of ‘clear’ or ‘almost clear’ with at least a 2-step improvement) at Week 4 will be randomized to either active treatment or vehicle twice weekly (3 to 4 days apart) for up to 52 weeks. Relapses (PGA score of at least ‘mild’), will be treated with Cal/BD aerosol foam once daily for up to 4 weeks until clearance is achieved; then twice weekly maintenance regimen will be resumed. If clearance is not regained within 4 weeks, the patients will leave the trial. Thus, the trial will compare two ways of using Cal/BD aerosol foam: a proactive approach with fixed twice-weekly maintenance regimen versus a conventional, reactive approach. The primary endpoint is time to first relapse. A total of 380 patients will be randomized in the trial, which is recruiting at approximately 50 sites in 5 countries. It is planned to enrol the first patient in Q4 2016. The results from this trial will add significantly to our knowledge on maintenance treatment of plaque psoriasis. Important data on long-term safety and efficacy of Cal/BD aerosol foam will be generated to show the potential of a convenient, well-tolerated fixed combination treatment for the maintenance of remission.
Background: Although rosacea can have a variable presentation, erythema and flushing are consistently observed in most patients. The objective of this study was to evaluate the safety and efficacy of incobotulinumtoxinA in reducing the primary symptoms of rosacea. Methods: Subjects (N ¼ 9) with erythematotelangiectactic or papulopustular rosacea, were randomized to receive up to 20 U of incobotulinumtoxinA injected in the affected area on both cheeks (Group 1; n ¼ 4) or equal volumes of a saline solution (Group 2; n ¼ 5). Assessments at baseline and at 1, 4, 12, and 16 weeks posttreatment included Rosacea Clinical Scores (RCS) and subject satisfaction. At week 16, both groups received incobotulinumtoxinA injections in the affected areas in both cheeks. Assessments were performed at 1 and 4 weeks post-retreatment. Results: A reduction in the primary features of rosacea was observed among subjects in Group 1 within 4 weeks of treatment with incobotulinumtoxinA as assessed by RCS. Subjects in Group 2 did not demonstrate any improvement in the features of rosacea following the saline injection. After receiving incobotulinumtoxinA treatment at week 16, subjects in Group 2 exhibited reductions in all of the primary and some of the secondary features of rosacea upon treatment with incobotulinumtoxinA. Subject satisfaction was higher among those receiving incobotulinumtoxinA treatment compared with placebo following the initial injection. Subjects in Group 2 who received incobotulinumtoxinA at week 16 reported higher satisfaction following retreatment. Conclusions: IncobotulinumtoxinA may be a safe and effective method to reduce the severity of rosacea symptoms and increase patient satisfaction. Commercial support: This study was supported by Merz North America, Inc.
Commercial support: LEO Pharma A/S funded this study.
5045 A pilot study - Safety and efficacy of fermented olive tree leaf extracts for chronic paronychia and Neoscytalidium dimidiatum onychomycosis treatment Pattriya Chanyachailert, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Summanas Bunyaratavej, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Charussri Leeyaphan, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Waritch Kobwanthanakun, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Chuda Rujitharanawong, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Sutasinee Phaitoonwattanakij, MD, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University; Kamonpan Lertrujiwanit, BS, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Introduction: Chronic paronychia and nondermatophyte onychomycosis are the common nail infections worldwide. Neoscytalidium dimidiatum is recognized as the recalcitrant organisms especially in tropical countries. Antifungal property in Olea europaea leaf extracts has been reported in vitro studies. Objective: Objective of this study was to evaluate efficacy and safety of O europaea leaf extraction for the treatment at 6 months. Methods: A pilot prospective study was conducted in patients with chronic paronychia and with nondermatophyte onychomycosis. O europaea leaf extracts were applied twice a day with self-mechanical reduction by nail emery. Chronic paronychia grading, normal nail length for non-dermatophyte onychomycosis, fungal microscopic examination, and fungal culture were recorded at first time visit, 2-, 4-, and 6-months after the treatment. Clinical and laboratory assessment by 2 dermatologists at each visit was compared to the first visit. Results: Nine female patients diagnosed as chronic paronychia were enrolled. Mean age (SD) was 60.1 ( 6 10.6) years. The affected sites were 7 thumbnails and 2 index finger nails. Mean severity grading was grade 3; ranged from grade 1-4. Culture revealed Candida albicans in all patients. Comparing with baseline at the first visit, severity of chronic paronychia was significantly reduced within 6 months after treating with O europaea leaf extracts (P ¼ .021). Complete cure for chronic paronychia was 56% at 6 months after treatment. For nondermatophyte onychomycosis, 6 male and 3 female patients were included. Mean age (SD) was 67.2 (6 7.9) years. All patients had N dimidiatum onychomycosis. Big toenails were affected in all patients. Mean normal nail length was 7.1 (6 1.2) mm. After treating with O europaea leaf extracts, mean normal nail toenail length at 4- and 6- month periods were 8.4 (6 0.8) and 8.9 (6 0.8) mm consequently, which demonstrated significant improvement when compared to mean normal nail length at first visit (P ¼ .047, P ¼ .016, respectively). Complete cure for nondermatophyte onychomycosis was 22% at 6 months after treatment, however, 78% had the clinical cure and 33% achieved mycological cure after 6-month treatment. No adverse event was observed in the study. Conclusion: O europaea leaf extracts could be an effective alternative topical treatment for chronic paronychia from C albicans infection and N dimidiatum onychomycosis. Commercial support: None identified.
JUNE 2017
4524 A population based cohort study of atopic dermatitis among young adult males in Singapore Wai Leong Kok, MBBS, Singapore Armed Forces; Yik Weng Yew, MBBS, National Skin Centre; Tien Guan Steven Thng, MBBS, National Skin Centre Background: Atopic dermatitis is a chronic relapsing condition with significant morbidity. There is a relative lack of data on the prevalence in the young adult age group in an urbanized, multicultural society such as Singapore. The objective of the study was to determine the period prevalence trends in a cohort of young adult males in Singapore over a five year period, as well as the demographic factors and coexisting medical conditions. Methods: A population based retrospective cohort study utilizing existing electronic medical records of baseline medical screening of young males conscripted into military service in Singapore over a five-year period was performed. Results: The period prevalence of atopic dermatitis among Singaporean male young adults was 9.76%, with a significant trend of increasing severity over the years. Moreover, increase in body mass index was associated with moderate or severe atopic dermatitis. Conclusion: The period prevalence of atopic dermatitis in young adults in Singapore is on a decreasing trend, albeit with a higher proportion of moderate or severe atopic dermatitis cases. Commercial support: None identified.
J AM ACAD DERMATOL
AB21