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Efficacy of a comprehensive serum in Thai subjects with moderate to severe facial hyperpigmentation
5623
5391
Efficacy comparison of ustekinumab between anti-tumor necrosis factor-a drug-na€ıve and anti-tumor necrosis factor-a drugresistant psoriasis patients Patricio L opez Jimenez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Jorge Alonso Suarez Perez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Enrique Herrera Acosta, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Marıa Victoria Mendiola Fernandez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Pablo Fernandez Crehuet, Dermatology Unit Hospital de Alta Resoluci on de And ujar; Francisco Guimera Martın-Neda, Dermatology Unit Hospital Universitario de Canarias Introduction: Recently, biologics have emerged as novel treatment options for patients with moderate to severe psoriasis. In Japan, infliximab and adalimumab, tumor necrosis factor- alpha (TNF-a) antagonists, were approved in 2010. Then in 2011, ustekinumab, a human anti-interleukin-12/23 monoclonal antibody, emerged as a new targeted therapy for psoriasis. However, whether therapeutic failure with a TNF-a antagonist affects a subsequent response to ustekinumab is not clear.
Efficacy of a comprehensive serum in Thai subjects with moderate to severe facial hyperpigmentation Elizabeth Makino, MBA, SkinMedica Inc., an Allergan Company; Priscilla Tan, SkinMedica Inc., an Allergan Company; Rahul Mehta, PhD, SkinMedica Inc., an Allergan Company
Methods: A multicenter retrospective study involving 70 patients with moderate to severe psoriasis (with or without PsA) treated with ustekinumab in three Dermatology Units at 3 hospitals in Spain is carried out; Hospital Universitario Virgen de la Victoria (Malaga), Hospital Universitario de Canarias y Hospital de Alta Resoluci on de And ujar (Ja en); patients were followed from 2009 until December 2011 in order to guarantee a minimum follow-up period of 156 weeks. Of the 70 patients enrolled, 55 received one or more biologic therapies prior to ustekinumab. The main objective of this study is to evaluate the survival rate of ustekinumab after 300 weeks of treatment in patients with moderate to severe psoriasis plaque and to determinate the reasons for the discontinuation in routine clinical practice. The survival rate, efficacy, and safety of ustekinumab in na€ıve patients were compared with patients with prior biological therapy. Results: There were no significant differences in the survival rate between treatment-na€ıve patients and those with prior biological therapy. Throughout the observation period (300 weeks), the overall drug survival rate for ustekinumab was 95.5%. No drop-outs were recorded in na€ıve-patients group. The survival rate for ustekinumab in patients who were previously exposed to only one biological therapy and those with two or more prior biological therapies was 97.1% and 90%, respectively. 84.8% of patients maintained PASI75 score at the end of follow-up. No patient discontinued the treatment due to a serious adverse event. Conclusions: Ustekinumab has showed a longer adherence in our cohort of psoriatic patients in routine clinical practice. Ustekinumab is an excellent therapeutic option for anti-TNF-a treatment failure but also as a first-line biologic treatment for psoriasis.
Facial hyperpigmentation is one of the first signs of aging and impacts patient quality of life. Efficacy of treatments should be assessed in a variety of ethnic populations because of variations in melanin biology. A double-blind, placebo-regimen controlled clinical study was conducted to assess the efficacy and tolerability of a novel comprehensive HQ-free and retinol-free serum (LYT2) in Thai subjects presenting with moderate to severe facial hyperpigmentation. Subjects were randomized 2:1 to receive LYT2 plus a sunscreen placebo regimen (cleanser, moisturizer and broad spectrum sunscreen SPF30+) or only the sunscreen placebo regimen. Subjects in the LYT2 group applied the serum twice daily after cleansing for eight weeks. Both groups used the cleanser and moisturizer twice daily, and applied the sunscreen in the morning and as needed throughout the day. Thirty-four female and male subjects aged 18-60 years completed the eight-week study (LYT2 n ¼ 22; sunscreen placebo regimen n ¼ 12). Clinical assessments for overall hyperpigmentation and blotch appearance (including color: light to dark, size: small to large, occurrence: slightly visible to highly visible, number: minimal to numerous, and homogeneity: very uneven to homogeneous) were graded by the blinded investigator at all visits (baseline and weeks 2, 4, and 8). Spectrophotometer instrumentation measurements for L* (brightness) were taken of normal and hyperpigmented lesions and the individual typological angle (ITA) was calculated for each subject. The LYT2 treated group demonstrated statistically significant improvements in all grading parameters, including overall hyperpigmentation, color, size, occurrence, number and homogeneity of blotches, at week 8 (all P # .01; Wilcoxon signed-rank test). The sunscreen placebo regimen only showed significant improvements in one of the grading parameters, blotch color, at week 8 (P # .003; Wilcoxon signed-rank test). Instrumentation measurements for L* (brightness) and ITA values supported the investigator grading results for the LYT2 group, showing significant improvements for both pigmented lesions and normal skin at weeks 2, 4 and 8 (all P # .001; Student’s t test). By week 8, 100% of subjects showed improvements in L* and ITA values in the LYT2 group compared to 83% of subjects in the sunscreen placebo regimen group. Both groups were well-tolerated with mean scores for tolerability parameters remaining mild or below throughout the study duration. Results from this study support the efficacy and tolerability of this novel comprehensive serum in improving the appearance of facial hyperpigmentation in Thai subjects. Commercial support: 100% sponsored by SkinMedica, an Allergan Company.
Commercial support: None identified.
5388 Efficacy of a comprehensive serum in Japanese subjects with moderate to severe facial hyperpigmentation Elizabeth Makino, MBA, SkinMedica Inc., an Allergan Company; Priscilla Tan, SkinMedica Inc., an Allergan Company; Rahul Mehta, PhD, SkinMedica Inc., an Allergan Company A double-blind, placebo-regimen controlled clinical study was conducted to assess the efficacy and tolerability of a novel comprehensive HQ-free and retinol-free serum (LYT2) in Japanese subjects presenting with moderate to severe facial hyperpigmentation. Subjects were randomized 2:1 to receive LYT2 plus a sunscreen placebo regimen (cleanser, moisturizer, and broad spectrum sunscreen SPF 30) or only the sunscreen placebo regimen. Subjects in the LYT2 group applied the serum twice daily after cleansing for eight weeks. Both groups used the cleanser and moisturizer twice daily, and applied the sunscreen in the morning and as needed throughout the day. Thirty-five female and male subjects aged 37-67 years completed the twelveweek study (LYT2 n ¼ 23; sunscreen placebo regimen n ¼ 12). Clinical assessments for overall hyperpigmentation and skin tone evenness by the blinded investigator and standardized digital photography were conducted at all visits (baseline and weeks 4, 8, and 12). Subjects treated with LYT2 showed early significant reductions in both mean overall hyperpigmentation and skin tone evenness scores at week 4, with continuing significant reductions through week 12 (all P # .02 compared to baseline; Wilcoxon signed-rank test). Subjects in the sunscreen placebo regimen did not show significant improvements until week 8 (for overall hyperpigmentation) or until week 12 (for skin tone evenness). LYT2 showed significantly greater improvements in skin tone evenness scores compared to the sunscreen placebo regimen at weeks 4 and 12 (all P # .03 treatment comparisons; Wilcoxon rankedsum test). Standardized digital photographs support the overall improvements observed by the investigator. Both treatments were well-tolerated with mean tolerability scores remaining mild or below throughout the study duration. Assessing the efficacy of product in a variety of ethnicities is important due to innate differences in melanin biology. Results from this study support the efficacy and tolerability of this novel comprehensive serum in improving the appearance of facial hyperpigmentation in Japanese subjects. Commercial support: 100% sponsored by SkinMedica, an Allergan Company.
AB118
J AM ACAD DERMATOL
5360 Efficacy of a hand protection cream used alone followed by in a regimen in subjects with occupational irritant contact dermatitis Philippe Humbert, MD, CHRU, Department of Dermatology; Ferial Fanian, MD, CHRU, Department of Dermatology; Matthew H. Meckfessel, PhD, Galderma Laboratories, L.P.; Mathieu Grivet-Seyve, PhD, Galderma, R&D Hand exposure to irritating substances, such as chemicals, soaps, disinfectants, and frequent hand washing, is common for those in many industries. Chronic exposure to these insults can result in irritation, dryness, and occupational irritant contact dermatitis (OICD). A 2-step regimen consisting of a protection cream (EP; Excipial Daily Protection Hand Cream, Galderma Laboratories, L.P.) and a repair cream (ER; Excipial Rapid Repair Hand Cream, Galderma Laboratories, L.P.) to help mitigate insults that may lead to OICD. EP helps shield and protect hands from external insult during the day and ER restores hydration and skin barrier function in the evening. A 14-day study was conducted in subjects with a history of OICD to assess the efficacy of EP alone for 7 days followed by EP+ER for an additional 7 days. Subjects applied EP at least BID and as needed for the entire study duration and ER QD in the evening for the last 7 days. The primary endpoint was improvement in investigator assessments including roughness, dryness, discomfort, and itching. Secondary endpoints included corneometry, transepidermal water loss (TEWL), and a subject questionnaire. A significant improvement in investigator assessments, corneometry, and TEWL was observed for the first 7 days. Roughness, discomfort, and hydration also significantly improved from day 7 to day 14 indicating additional benefit of the addition of ER. Both products were well tolerated and subjects indicated a high satisfaction. The results of this study support the use of this regimen in subjects prone to OICD, which may help alleviate symptoms commonly faced by this population. Commercial support: Galderma R&D funded this study.
JUNE 2017
5391
Efficacy comparison of ustekinumab between anti-tumor necrosis factor-a drug-na€ıve and anti-tumor necrosis factor-a drugresistant psoriasis patients Patricio L opez Jimenez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Jorge Alonso Suarez Perez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Enrique Herrera Acosta, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Marıa Victoria Mendiola Fernandez, Dermatology Unit Hospital Clınico Universitario Virgen de la Victoria; Pablo Fernandez Crehuet, Dermatology Unit Hospital de Alta Resoluci on de And ujar; Francisco Guimera Martın-Neda, Dermatology Unit Hospital Universitario de Canarias Introduction: Recently, biologics have emerged as novel treatment options for patients with moderate to severe psoriasis. In Japan, infliximab and adalimumab, tumor necrosis factor- alpha (TNF-a) antagonists, were approved in 2010. Then in 2011, ustekinumab, a human anti-interleukin-12/23 monoclonal antibody, emerged as a new targeted therapy for psoriasis. However, whether therapeutic failure with a TNF-a antagonist affects a subsequent response to ustekinumab is not clear.
Efficacy of a comprehensive serum in Thai subjects with moderate to severe facial hyperpigmentation Elizabeth Makino, MBA, SkinMedica Inc., an Allergan Company; Priscilla Tan, SkinMedica Inc., an Allergan Company; Rahul Mehta, PhD, SkinMedica Inc., an Allergan Company
Methods: A multicenter retrospective study involving 70 patients with moderate to severe psoriasis (with or without PsA) treated with ustekinumab in three Dermatology Units at 3 hospitals in Spain is carried out; Hospital Universitario Virgen de la Victoria (Malaga), Hospital Universitario de Canarias y Hospital de Alta Resoluci on de And ujar (Ja en); patients were followed from 2009 until December 2011 in order to guarantee a minimum follow-up period of 156 weeks. Of the 70 patients enrolled, 55 received one or more biologic therapies prior to ustekinumab. The main objective of this study is to evaluate the survival rate of ustekinumab after 300 weeks of treatment in patients with moderate to severe psoriasis plaque and to determinate the reasons for the discontinuation in routine clinical practice. The survival rate, efficacy, and safety of ustekinumab in na€ıve patients were compared with patients with prior biological therapy. Results: There were no significant differences in the survival rate between treatment-na€ıve patients and those with prior biological therapy. Throughout the observation period (300 weeks), the overall drug survival rate for ustekinumab was 95.5%. No drop-outs were recorded in na€ıve-patients group. The survival rate for ustekinumab in patients who were previously exposed to only one biological therapy and those with two or more prior biological therapies was 97.1% and 90%, respectively. 84.8% of patients maintained PASI75 score at the end of follow-up. No patient discontinued the treatment due to a serious adverse event. Conclusions: Ustekinumab has showed a longer adherence in our cohort of psoriatic patients in routine clinical practice. Ustekinumab is an excellent therapeutic option for anti-TNF-a treatment failure but also as a first-line biologic treatment for psoriasis.
Facial hyperpigmentation is one of the first signs of aging and impacts patient quality of life. Efficacy of treatments should be assessed in a variety of ethnic populations because of variations in melanin biology. A double-blind, placebo-regimen controlled clinical study was conducted to assess the efficacy and tolerability of a novel comprehensive HQ-free and retinol-free serum (LYT2) in Thai subjects presenting with moderate to severe facial hyperpigmentation. Subjects were randomized 2:1 to receive LYT2 plus a sunscreen placebo regimen (cleanser, moisturizer and broad spectrum sunscreen SPF30+) or only the sunscreen placebo regimen. Subjects in the LYT2 group applied the serum twice daily after cleansing for eight weeks. Both groups used the cleanser and moisturizer twice daily, and applied the sunscreen in the morning and as needed throughout the day. Thirty-four female and male subjects aged 18-60 years completed the eight-week study (LYT2 n ¼ 22; sunscreen placebo regimen n ¼ 12). Clinical assessments for overall hyperpigmentation and blotch appearance (including color: light to dark, size: small to large, occurrence: slightly visible to highly visible, number: minimal to numerous, and homogeneity: very uneven to homogeneous) were graded by the blinded investigator at all visits (baseline and weeks 2, 4, and 8). Spectrophotometer instrumentation measurements for L* (brightness) were taken of normal and hyperpigmented lesions and the individual typological angle (ITA) was calculated for each subject. The LYT2 treated group demonstrated statistically significant improvements in all grading parameters, including overall hyperpigmentation, color, size, occurrence, number and homogeneity of blotches, at week 8 (all P # .01; Wilcoxon signed-rank test). The sunscreen placebo regimen only showed significant improvements in one of the grading parameters, blotch color, at week 8 (P # .003; Wilcoxon signed-rank test). Instrumentation measurements for L* (brightness) and ITA values supported the investigator grading results for the LYT2 group, showing significant improvements for both pigmented lesions and normal skin at weeks 2, 4 and 8 (all P # .001; Student’s t test). By week 8, 100% of subjects showed improvements in L* and ITA values in the LYT2 group compared to 83% of subjects in the sunscreen placebo regimen group. Both groups were well-tolerated with mean scores for tolerability parameters remaining mild or below throughout the study duration. Results from this study support the efficacy and tolerability of this novel comprehensive serum in improving the appearance of facial hyperpigmentation in Thai subjects. Commercial support: 100% sponsored by SkinMedica, an Allergan Company.
Commercial support: None identified.
5388 Efficacy of a comprehensive serum in Japanese subjects with moderate to severe facial hyperpigmentation Elizabeth Makino, MBA, SkinMedica Inc., an Allergan Company; Priscilla Tan, SkinMedica Inc., an Allergan Company; Rahul Mehta, PhD, SkinMedica Inc., an Allergan Company A double-blind, placebo-regimen controlled clinical study was conducted to assess the efficacy and tolerability of a novel comprehensive HQ-free and retinol-free serum (LYT2) in Japanese subjects presenting with moderate to severe facial hyperpigmentation. Subjects were randomized 2:1 to receive LYT2 plus a sunscreen placebo regimen (cleanser, moisturizer, and broad spectrum sunscreen SPF 30) or only the sunscreen placebo regimen. Subjects in the LYT2 group applied the serum twice daily after cleansing for eight weeks. Both groups used the cleanser and moisturizer twice daily, and applied the sunscreen in the morning and as needed throughout the day. Thirty-five female and male subjects aged 37-67 years completed the twelveweek study (LYT2 n ¼ 23; sunscreen placebo regimen n ¼ 12). Clinical assessments for overall hyperpigmentation and skin tone evenness by the blinded investigator and standardized digital photography were conducted at all visits (baseline and weeks 4, 8, and 12). Subjects treated with LYT2 showed early significant reductions in both mean overall hyperpigmentation and skin tone evenness scores at week 4, with continuing significant reductions through week 12 (all P # .02 compared to baseline; Wilcoxon signed-rank test). Subjects in the sunscreen placebo regimen did not show significant improvements until week 8 (for overall hyperpigmentation) or until week 12 (for skin tone evenness). LYT2 showed significantly greater improvements in skin tone evenness scores compared to the sunscreen placebo regimen at weeks 4 and 12 (all P # .03 treatment comparisons; Wilcoxon rankedsum test). Standardized digital photographs support the overall improvements observed by the investigator. Both treatments were well-tolerated with mean tolerability scores remaining mild or below throughout the study duration. Assessing the efficacy of product in a variety of ethnicities is important due to innate differences in melanin biology. Results from this study support the efficacy and tolerability of this novel comprehensive serum in improving the appearance of facial hyperpigmentation in Japanese subjects. Commercial support: 100% sponsored by SkinMedica, an Allergan Company.
AB118
J AM ACAD DERMATOL
5360 Efficacy of a hand protection cream used alone followed by in a regimen in subjects with occupational irritant contact dermatitis Philippe Humbert, MD, CHRU, Department of Dermatology; Ferial Fanian, MD, CHRU, Department of Dermatology; Matthew H. Meckfessel, PhD, Galderma Laboratories, L.P.; Mathieu Grivet-Seyve, PhD, Galderma, R&D Hand exposure to irritating substances, such as chemicals, soaps, disinfectants, and frequent hand washing, is common for those in many industries. Chronic exposure to these insults can result in irritation, dryness, and occupational irritant contact dermatitis (OICD). A 2-step regimen consisting of a protection cream (EP; Excipial Daily Protection Hand Cream, Galderma Laboratories, L.P.) and a repair cream (ER; Excipial Rapid Repair Hand Cream, Galderma Laboratories, L.P.) to help mitigate insults that may lead to OICD. EP helps shield and protect hands from external insult during the day and ER restores hydration and skin barrier function in the evening. A 14-day study was conducted in subjects with a history of OICD to assess the efficacy of EP alone for 7 days followed by EP+ER for an additional 7 days. Subjects applied EP at least BID and as needed for the entire study duration and ER QD in the evening for the last 7 days. The primary endpoint was improvement in investigator assessments including roughness, dryness, discomfort, and itching. Secondary endpoints included corneometry, transepidermal water loss (TEWL), and a subject questionnaire. A significant improvement in investigator assessments, corneometry, and TEWL was observed for the first 7 days. Roughness, discomfort, and hydration also significantly improved from day 7 to day 14 indicating additional benefit of the addition of ER. Both products were well tolerated and subjects indicated a high satisfaction. The results of this study support the use of this regimen in subjects prone to OICD, which may help alleviate symptoms commonly faced by this population. Commercial support: Galderma R&D funded this study.
JUNE 2017