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Safety and efficacy of calcium hydroxylapatite dermal filler for hand treatment
1095
361
Relationship between mid-face volume loss and the appearance of tear trough and nasolabial folds: Results from a multinational panel study Dee Anna Glaser, MD, Saint Louis University School of Medicine, Saint Louis, MO, United States; Andrew Magyar, PhD, Allergan, Inc, Bridgewater, NJ, United States; Conor Gallagher, PhD, Allergan, Inc, Irvine, CA, United States
Safety and efficacy of calcium hydroxylapatite dermal filler for hand treatment: A 12-month open-label extension study Mitchel Goldman, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc, San Diego, CA, United States; Amir Moradi, MD, private practice, Vista, CA, United States; Bruce Katz, MD, Juva Skin & Laser Center, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Kaveh Alizadeh, MD, Cosmo Plastic Surgery, LLC, Great Neck, NY, United States; Jeffrey Adelglass, MD, Texas Pharmaceutical Research LP, Plano, TX, United States
Objective: To understand the effect of mid-face (MF) volume loss on adjacent facial areas among men and women of different race/ethnic groups. Methods: A cross-sectional, web-based survey was administered to health panel participants in the United States, Canada, United Kingdom, and Australia in early 2014. Male and female participants 18-75 years old were recruited based on a sociodemographic sampling framework designed to ensure adequate representation of each subgroup of interest. Exclusion criteria included prior facial trauma or treatments (eg, plastic surgery, injectables, prescription retinoids). Participants compared their facial characteristics against photonumeric scales depicting various degrees of severity for a number of characteristics including MF volume, tear troughs (TTs), nasolabial folds (NLFs). Ordinal logistic regressions were conducted to assess the impact of MF volume on severity of TTs and NLFs controlling for the following predictor variables: gender, age, race/ethnicity, BMI, and country. Correlations between MF volume, TTs, and NLFs were plotted by age (categorized in 10-year cohorts) separately by race/ethnicity and gender. Results: 4086 participants completed the survey (80.0% female, 40.7% white, 22.3% Asian, 21.0% black, 15.9% Latino/Hispanic) (mean age ¼ 47.0 6 16.1 years), and 3553 had complete data. Demographic data suggest that the study population was aligned with general population norms from each country. All correlations were found to be positive and statistically significant, and descriptive statistics showed differences in the rate of progression of facial feature severity between race/ethnic groups. Increasing severity of MF volume loss resulted in increasing severity of TTs and NLFs (P \.0001). MF volume loss was the strongest predictor of increasing severity of NLFs, with an odds ratio of 1.5. MF volume loss predicted increasing TT severity, with an odds ratio of 1.6. Conclusion: Results indicated MF volume loss significantly predicted the severity of TT deformity and NLFs. Although this is based on a cross-sectional analysis, these data suggest that progression of MF volume loss or fat redistribution may lead to the development of infraorbital hollowing and the prominence of NLFs in an agedependent manner. 100% is Sponsored by Allergan, Inc.
Calcium hydroxylapatite microspheres suspended in a carrier gel (CaHA; Merz North America, Inc) has demonstrated significant improvement in hand appearance following a single injection up to 3 mos after treatment. This open label extension (OLEX) study assessed the safety and effectiveness of CaHA up to 12 mos after initial treatment and a retreatment interval of 6 mos. This multicenter, randomized, controlled, single-blind study comprised a 3 month main study (reported separately) followed by this OLEX study through 12 mos. 85 subjects were randomized to a treatment group and 29 to a delayed treatment group. Treatment group subjects were treated at enrollment and delayed treatment group subjects returned at 3 mos for comparative assessment and then received treatment. Subjects were eligible for retreatment 6 mos after initial treatment, and 69.0% of subjects received a retreatment. Subjects received CaHA mixed with 2% lidocaine-HCl in the dorsum of both hands. Effectiveness was measured by evaluating changes from baseline in hand appearance at 6, 9 and 12 mos using the Merz Hand Grading Scale and the Global Aesthetic Improvement Scale. Safety was assessed by monitoring all AEs, in addition to a series of real-time hand function tests. 111 of 114 subjects completed the OLEX through 12 mos. 95.6% of subjects were female and 76.3% Caucasian with a mean age of 53.3 years. A significant improvement in MHGS ratings was demonstrated at all time points after initial treatment when compared to baseline (P \. 0001). Product durability was demonstrated with significant improvement in MHGS ratings at 12 mos in subjects not receiving retreatment, with 71.7% of hands and 68.2% of subjects with both hands ¼ 1 point improved compared to baseline (P \ .0001). Significant mean change MHGS improvement was demonstrated up to 6 mos after retreatment with 88.3% of hands and 88.5% of subjects with both hands ¼ 1 point improved compared to baseline (P \ .0001). In addition, [ 93% of all subjects reported the treated hands were at least ‘‘Improved’’ at 6 mos after initial treatment and retreatment. The AEs observed were expected. Subjects receiving retreatment reported a lower incidence of bruising, swelling, redness, pain, and itching after retreatment when compared to initial treatment. There was no negative clinical impact on hand function post treatment(s). CaHA results in a significant improvement in hand appearance and is well tolerated for aesthetic hand treatment. 100% sponsored by Merz North America, Inc.
1801 Safety and efficacy of calcium hydroxylapatite dermal filler for hand treatment Mitchel Goldman, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc, San Diego, CA, United States; Amir Moradi, MD, private practice, Vista, CA, United States; Bruce Katz, MD, Juva Skin & Laser Center, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Kaveh Alizadeh, MD, Cosmo Plastic Surgery, LLC, Great Neck, NY, United States; Jeffrey Adelglass, MD, Texas Pharmaceutical Research LP, Plano, TX, United States Calcium hydroxylapatite microspheres suspended in a carrier gel (CaHA; Merz North America, Inc) has demonstrated significant improvement in the appearance of the dorsal side of the hand up to 1 month after treatment with CaHA. The purpose of this study was to assess the safety and effectiveness of CaHA through 3 months after hand treatment. This was a multicenter, randomized, controlled, single-blind study of 114 subjects: 85 randomized to a treatment group and 29 randomized to a control group. Subjects randomized to the treatment group were treated at enrollment and subjects randomized to the control group returned at 3 months for comparative assessment and then received treatment. All subjects were followed through 12 months from study enrollment in an open label extension (OLEX) study (to be reported separately). Subjects received injections of CaHA mixed with 2% lidocaineHCl in the dorsum of both hands. Effectiveness was measured by evaluating changes in hand appearance at 3 months using the following live assessment tools: the Merz Hand Grading Scale (MHGS; a 5-point scale used to grade appearance of the dorsal side of the hand on (0 ¼ no loss of fatty tissue; 4 ¼ very severe loss of fatty tissue; marked visibility of veins and tendons) by a blinded evaluator and the Global Aesthetic Improvement Scale (GAIS; a 5-point relative scale from ‘‘Very Much Improved’’ to ‘‘Worse’’). Safety was assessed by recording all AEs observed during the study. One hundred-thirteen (113) of 114 subjects completed the study. The majority of subjects were female (95.6%) and Caucasian (76.3%) with a mean age of 53.3 years. A significant improvement in MHGS ratings was demonstrated in the treatment group at 3 months when compared to baseline (2.6 vs 1.5; P\. 0001) and to the control group (-1.1 vs -0.1; P \. 0001). Seventy-seven percent (77%) of hands in the treatment group showed ¼ 1 point improvement and 75% of subjects showed ¼ 1 point improvement in both hands (P \.0001). In addition, the treatment group reported 98% (166/170 hands) of the treated hands were at least ‘‘Improved’’ at 3 months when compared to baseline appearance. The AEs reported during this study were expected and typical of other CaHA studies. Bruising, swelling, redness, and pain were the most frequently reported AEs. Calcium hydroxylapatite results in a significant improvement in hand appearance following a single injection and is well tolerated for aesthetic hand treatment. 100% is Sponsored by Merz North America, Inc.
AB20
J AM ACAD DERMATOL
822 Skin even tone and spots reducing by enhancing ascorbic acid permeation through a two component system designed based on partition coefficient Cinthia Fernanda Zanatta, PharmD, Johnson & Johnson do Brasil Ind ustria e Comercio, S~ao Paulo, Brazil; Cristina W€ ohlke Vendruscolo, MS, Johnson & Johnson do Brasil Ind ustria e Comercio, S~ao Paulo, Brazil; Filomena Augusta Macedo, Johnson & Johnson Consumer Companies Inc, Skillman, NJ, United States Objective: The aim of this work was to develop a stable cosmetic formulation with high concentration of L-ascorbic (16%), and evaluate its in vivo lightening efficacy. Background: Stabilizing vitamin C in a cosmetic product is challenging, due to its high reactivity. Several attempts were done to stabilize L-ascorbic acid in an O/W emulsion but failed, since presence of water increases oxidation reaction speed, especially when exposed to heat. Final attempt was to isolate vitamin C from water in an anhydrous silicone crosspolymer formula. However, it is known in literature that polar molecules require specific carrier systems and ideal partition coefficient to penetrate skin. To achieve this ideal vehicle to transport vitamin C, a moisturizer was designed with permeation enhancers such as squalene, glycerine; and sorbitan olivate. This moisturizer should be premixed with the anhydrous formula containing L-ascorbic acid in 50:50 ratio, prior to facial application. In summary, we have one product separated in two formulas (anhydrous base with vitamin C, and a moisturizer in two different packages). Methods: Permeation test: Franz cells using pig ear skin. Lightening effect: dermatologic clinical trial to evaluate improving the uniformity of skin tone e in use test. Results: Physical-chemical stability tests were successfully finished for the anhydrous silicone formula containing L-ascorbic acid and for the moisturizer. Ascorbic acid concentration was measured after 12 weeks of stability and no significant differences were observed when compared to initial concentration. Permeation test showed that the cutaneous retention of the active in the epidermis + dermis after 8 hours was 63 6 27 g/cm2 for the combination of two formulas (anhydrous formula and moisturizer), and 28 6 10 g/cm2 for the anhydrous formula alone. This enhanced permeation was confirmed by efficacious results in vivo. Approximately 35,0% of subjects clinically assed presented significant improvement in skin tone uniformity and spots reduction after 60 days of in use test. Johnson & Johnson Consumer Companies, Inc.
MAY 2015
361
Relationship between mid-face volume loss and the appearance of tear trough and nasolabial folds: Results from a multinational panel study Dee Anna Glaser, MD, Saint Louis University School of Medicine, Saint Louis, MO, United States; Andrew Magyar, PhD, Allergan, Inc, Bridgewater, NJ, United States; Conor Gallagher, PhD, Allergan, Inc, Irvine, CA, United States
Safety and efficacy of calcium hydroxylapatite dermal filler for hand treatment: A 12-month open-label extension study Mitchel Goldman, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc, San Diego, CA, United States; Amir Moradi, MD, private practice, Vista, CA, United States; Bruce Katz, MD, Juva Skin & Laser Center, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Kaveh Alizadeh, MD, Cosmo Plastic Surgery, LLC, Great Neck, NY, United States; Jeffrey Adelglass, MD, Texas Pharmaceutical Research LP, Plano, TX, United States
Objective: To understand the effect of mid-face (MF) volume loss on adjacent facial areas among men and women of different race/ethnic groups. Methods: A cross-sectional, web-based survey was administered to health panel participants in the United States, Canada, United Kingdom, and Australia in early 2014. Male and female participants 18-75 years old were recruited based on a sociodemographic sampling framework designed to ensure adequate representation of each subgroup of interest. Exclusion criteria included prior facial trauma or treatments (eg, plastic surgery, injectables, prescription retinoids). Participants compared their facial characteristics against photonumeric scales depicting various degrees of severity for a number of characteristics including MF volume, tear troughs (TTs), nasolabial folds (NLFs). Ordinal logistic regressions were conducted to assess the impact of MF volume on severity of TTs and NLFs controlling for the following predictor variables: gender, age, race/ethnicity, BMI, and country. Correlations between MF volume, TTs, and NLFs were plotted by age (categorized in 10-year cohorts) separately by race/ethnicity and gender. Results: 4086 participants completed the survey (80.0% female, 40.7% white, 22.3% Asian, 21.0% black, 15.9% Latino/Hispanic) (mean age ¼ 47.0 6 16.1 years), and 3553 had complete data. Demographic data suggest that the study population was aligned with general population norms from each country. All correlations were found to be positive and statistically significant, and descriptive statistics showed differences in the rate of progression of facial feature severity between race/ethnic groups. Increasing severity of MF volume loss resulted in increasing severity of TTs and NLFs (P \.0001). MF volume loss was the strongest predictor of increasing severity of NLFs, with an odds ratio of 1.5. MF volume loss predicted increasing TT severity, with an odds ratio of 1.6. Conclusion: Results indicated MF volume loss significantly predicted the severity of TT deformity and NLFs. Although this is based on a cross-sectional analysis, these data suggest that progression of MF volume loss or fat redistribution may lead to the development of infraorbital hollowing and the prominence of NLFs in an agedependent manner. 100% is Sponsored by Allergan, Inc.
Calcium hydroxylapatite microspheres suspended in a carrier gel (CaHA; Merz North America, Inc) has demonstrated significant improvement in hand appearance following a single injection up to 3 mos after treatment. This open label extension (OLEX) study assessed the safety and effectiveness of CaHA up to 12 mos after initial treatment and a retreatment interval of 6 mos. This multicenter, randomized, controlled, single-blind study comprised a 3 month main study (reported separately) followed by this OLEX study through 12 mos. 85 subjects were randomized to a treatment group and 29 to a delayed treatment group. Treatment group subjects were treated at enrollment and delayed treatment group subjects returned at 3 mos for comparative assessment and then received treatment. Subjects were eligible for retreatment 6 mos after initial treatment, and 69.0% of subjects received a retreatment. Subjects received CaHA mixed with 2% lidocaine-HCl in the dorsum of both hands. Effectiveness was measured by evaluating changes from baseline in hand appearance at 6, 9 and 12 mos using the Merz Hand Grading Scale and the Global Aesthetic Improvement Scale. Safety was assessed by monitoring all AEs, in addition to a series of real-time hand function tests. 111 of 114 subjects completed the OLEX through 12 mos. 95.6% of subjects were female and 76.3% Caucasian with a mean age of 53.3 years. A significant improvement in MHGS ratings was demonstrated at all time points after initial treatment when compared to baseline (P \. 0001). Product durability was demonstrated with significant improvement in MHGS ratings at 12 mos in subjects not receiving retreatment, with 71.7% of hands and 68.2% of subjects with both hands ¼ 1 point improved compared to baseline (P \ .0001). Significant mean change MHGS improvement was demonstrated up to 6 mos after retreatment with 88.3% of hands and 88.5% of subjects with both hands ¼ 1 point improved compared to baseline (P \ .0001). In addition, [ 93% of all subjects reported the treated hands were at least ‘‘Improved’’ at 6 mos after initial treatment and retreatment. The AEs observed were expected. Subjects receiving retreatment reported a lower incidence of bruising, swelling, redness, pain, and itching after retreatment when compared to initial treatment. There was no negative clinical impact on hand function post treatment(s). CaHA results in a significant improvement in hand appearance and is well tolerated for aesthetic hand treatment. 100% sponsored by Merz North America, Inc.
1801 Safety and efficacy of calcium hydroxylapatite dermal filler for hand treatment Mitchel Goldman, MD, Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc, San Diego, CA, United States; Amir Moradi, MD, private practice, Vista, CA, United States; Bruce Katz, MD, Juva Skin & Laser Center, New York, NY, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Kaveh Alizadeh, MD, Cosmo Plastic Surgery, LLC, Great Neck, NY, United States; Jeffrey Adelglass, MD, Texas Pharmaceutical Research LP, Plano, TX, United States Calcium hydroxylapatite microspheres suspended in a carrier gel (CaHA; Merz North America, Inc) has demonstrated significant improvement in the appearance of the dorsal side of the hand up to 1 month after treatment with CaHA. The purpose of this study was to assess the safety and effectiveness of CaHA through 3 months after hand treatment. This was a multicenter, randomized, controlled, single-blind study of 114 subjects: 85 randomized to a treatment group and 29 randomized to a control group. Subjects randomized to the treatment group were treated at enrollment and subjects randomized to the control group returned at 3 months for comparative assessment and then received treatment. All subjects were followed through 12 months from study enrollment in an open label extension (OLEX) study (to be reported separately). Subjects received injections of CaHA mixed with 2% lidocaineHCl in the dorsum of both hands. Effectiveness was measured by evaluating changes in hand appearance at 3 months using the following live assessment tools: the Merz Hand Grading Scale (MHGS; a 5-point scale used to grade appearance of the dorsal side of the hand on (0 ¼ no loss of fatty tissue; 4 ¼ very severe loss of fatty tissue; marked visibility of veins and tendons) by a blinded evaluator and the Global Aesthetic Improvement Scale (GAIS; a 5-point relative scale from ‘‘Very Much Improved’’ to ‘‘Worse’’). Safety was assessed by recording all AEs observed during the study. One hundred-thirteen (113) of 114 subjects completed the study. The majority of subjects were female (95.6%) and Caucasian (76.3%) with a mean age of 53.3 years. A significant improvement in MHGS ratings was demonstrated in the treatment group at 3 months when compared to baseline (2.6 vs 1.5; P\. 0001) and to the control group (-1.1 vs -0.1; P \. 0001). Seventy-seven percent (77%) of hands in the treatment group showed ¼ 1 point improvement and 75% of subjects showed ¼ 1 point improvement in both hands (P \.0001). In addition, the treatment group reported 98% (166/170 hands) of the treated hands were at least ‘‘Improved’’ at 3 months when compared to baseline appearance. The AEs reported during this study were expected and typical of other CaHA studies. Bruising, swelling, redness, and pain were the most frequently reported AEs. Calcium hydroxylapatite results in a significant improvement in hand appearance following a single injection and is well tolerated for aesthetic hand treatment. 100% is Sponsored by Merz North America, Inc.
AB20
J AM ACAD DERMATOL
822 Skin even tone and spots reducing by enhancing ascorbic acid permeation through a two component system designed based on partition coefficient Cinthia Fernanda Zanatta, PharmD, Johnson & Johnson do Brasil Ind ustria e Comercio, S~ao Paulo, Brazil; Cristina W€ ohlke Vendruscolo, MS, Johnson & Johnson do Brasil Ind ustria e Comercio, S~ao Paulo, Brazil; Filomena Augusta Macedo, Johnson & Johnson Consumer Companies Inc, Skillman, NJ, United States Objective: The aim of this work was to develop a stable cosmetic formulation with high concentration of L-ascorbic (16%), and evaluate its in vivo lightening efficacy. Background: Stabilizing vitamin C in a cosmetic product is challenging, due to its high reactivity. Several attempts were done to stabilize L-ascorbic acid in an O/W emulsion but failed, since presence of water increases oxidation reaction speed, especially when exposed to heat. Final attempt was to isolate vitamin C from water in an anhydrous silicone crosspolymer formula. However, it is known in literature that polar molecules require specific carrier systems and ideal partition coefficient to penetrate skin. To achieve this ideal vehicle to transport vitamin C, a moisturizer was designed with permeation enhancers such as squalene, glycerine; and sorbitan olivate. This moisturizer should be premixed with the anhydrous formula containing L-ascorbic acid in 50:50 ratio, prior to facial application. In summary, we have one product separated in two formulas (anhydrous base with vitamin C, and a moisturizer in two different packages). Methods: Permeation test: Franz cells using pig ear skin. Lightening effect: dermatologic clinical trial to evaluate improving the uniformity of skin tone e in use test. Results: Physical-chemical stability tests were successfully finished for the anhydrous silicone formula containing L-ascorbic acid and for the moisturizer. Ascorbic acid concentration was measured after 12 weeks of stability and no significant differences were observed when compared to initial concentration. Permeation test showed that the cutaneous retention of the active in the epidermis + dermis after 8 hours was 63 6 27 g/cm2 for the combination of two formulas (anhydrous formula and moisturizer), and 28 6 10 g/cm2 for the anhydrous formula alone. This enhanced permeation was confirmed by efficacious results in vivo. Approximately 35,0% of subjects clinically assed presented significant improvement in skin tone uniformity and spots reduction after 60 days of in use test. Johnson & Johnson Consumer Companies, Inc.
MAY 2015