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A multicenter, randomized, double-blind study to evaluate the efficacy of onabotulinumtoxina (20 units) in the treatment of glabellar lines, when compared to incoboulinumtoxina (30 units)
A multicenter, randomized, double-blind study to evaluate the efficacy of onabotulinumtoxina (20 units) in the treatment of glabellar lines, when compared to incoboulinumtoxina (30 units)
(Poster reference number 5577)
Marion Moers-Carpi, MD, Hautok und Hautok-cosmetics, M€ unchen, Germany; Antony Fulford-Smith, MBBS, Allergan Ltd. (GB), Marlow, United Kingdom; Kelvin Tan, MBBCh, Allergan Ltd. (GB), Marlow, United Kingdom Background: The prescribing information for all type A botulinum toxins clearly identifies that each has unique potency units that are specific and not interchangeable. Previously reported potency data has shown that batches of onabotulinumtoxin A and incobotulinumtoxin A are not equipotent when tested in the Allergan LD50 assay. The purpose of this study was to explore the relative efficacy of different labeled doses of these two type A botulinum toxins for the treatment of glabellar lines in a clinical setting. Study design: Patients with moderate/severe glabellar lines were randomized in an appropriately powered double blind, comparative study of either onabotulinumtoxin A (20 units) or incobotulinumtoxin A (30 units). At days 28, 84, 98, and 112, physicians rated the severity of glabellar lines at maximum contraction using the Facial Wrinkle Scale (FWS). The primary endpoint was the proportion of responders within each treatment group based on the injector’s rating of FWS at maximum contraction at day 28. Treatment response was defined as achievement of 1 point or greater improvement in FWS at maximum contraction. Physicians also assessed adverse events (AEs) at all follow-up visits. Results: A total of 224 patients were randomized, 89.3% female, 98.7% white with median age 45 years (range 20-65). The groups were well balanced for age, sex, race, and stratified by moderate and severe on the FWS. At the primary endpoint, day 28, the number of responders in the onabotulinumtoxin A (20 units) group was 108 (96%), compared to 106 responders (95%) in the incobotulinumtoxin A (30 units) group. The results for the two groups were statistically comparable at the doses used in this study. Injector ratings of FWS in the two groups at days 84, 98, and 112 demonstrated a trend in favor of onabotulinumtoxin A and therefore did not show statistical equivalence. Forty-two AEs were reported, 3 were considered related to study medication (1 in onabotulinumtoxin A [20 unit] group and 2 in incobotulinumtoxin A (30 unit) group). Most AEs were mild, no patients were withdrawn due to AEs and no serious AEs were reported. Conclusions: In this randomized controlled study of labeled doses of different type A botulinum toxins, 20 units of onabotulinumtoxin A was as effective as 30 units of incobotulinumtoxin A, despite a 50% difference in unit doses.
A novel fluorescent assay used to measure the absorption efficacy of a sonic applicator
(Poster reference number 5574)
Greg Peterson, PhD, Pacific Bioscience Lab, Bellevue, WA, United States; Emily Henes, Pacific Bioscience Labs, Bellevue, WA, United States; Katherine Ortblad, MPH, Pacific Bioscience Laboratories, Bellevue, WA, United States; Michael Kearney, Pacific Bioscience Labs, Bellevue, WA, United States; Nina Koski, Pacific Bioscience Labs, Bellevue, WA, United States; Robert Akridge, PhD, Pacific Bioscience Labs, Bellevue, WA, United States Background: Eye serums/creams are typically applied to the delicate skin around the eye area using a gentle tapping motion of the ring finger. A sonic applicator was invented to replace manual application by generating gentle sonic pulses that rapidly (but gently) massages serums/eye creams into outer most layers of the stratum corneum. In order to determine the efficacy of this technology, a novel fluorescent serum-dye assay was developed to assess the efficacy of sonic application. Methods: A single-visit study was conducted to assessed absorption by different application methods. In this study a noninvasive fluorescent serum dye method, as well as photographs, and image analysis were used. A fluorescent marker was mixed into an antiaging sea serum and applied to the lower eye area, both manually and with the sonic applicator. The same volume of the serum dye mixture (z50 L) was applied to lower area of both eyes. Participants were instructed to apply the serum dye mixture to the right lower eye area using their ring finger as they normally would at home, and to the left lower eye area using the sonic applicator. Immediately after application, the serum dye mixture was blotted twice with an absorbent tissue in a consistent and systematic way to remove excess serum remaining on the surface of the skin. Photographs were taken using a Visia CR camera. Results: Ultraviolet images revealed a disproportional amount of fluorescent marker remaining on the sonically applied eye area. The fluorescence remaining around the eye area after application was quantified by using image analysis software [Image J 1.43; NIH]. Results were then compared statistically using a paired t test. A statistically significant difference (P ¼ .003) was detected between the manual and sonic application. Conclusion: Photographs and Image J analysis confirm that sonic application using a fluorescent marker results in more absorption into the stratum corneum. Commercial support: Pacific Bioscience Laboratories.
Commercial support: Sponsored by Allergan. K. Tan and A. Fulford-Smith are employees of Allergan.
A new clinical strength, multimechanism skin care regimen for photodamaged skin: Results from a vehicle-controlled clinical trial
(Poster reference number 4929)
Barbara A. Green, MS, NeoStrata Company, Inc, Princeton, NJ, United States; Brenda L. Edison, NeoStrata Company, Inc, Princeton, NJ, United States; Irina Brouda, NeoStrata Company, Inc, Princeton, NJ, United States; Patricia K. Farris, MD, Department of Dermatology, Tulane University School of Medicine, New Orleans, LA, United States; Ronni L. Weinkauf, PhD, NeoStrata Company, Inc, Princeton, NJ, United States
A novel tyrosine amino acid derivative as a topical wrinkle filler
(Poster reference number 5296)
Skin aging is a multifaceted biologic process that cannot be addressed by any single skin care ingredient. A clinical strength skin care regimen that delivers over 35% active benefit ingredients (hydroxyacids, N-acetylglucosamine, retinol, peptides, antioxidants, and apple stem cell extract) was developed to provide antiaging benefits across all skin layers via multiple mechanisms. The regimen consists of a facial cleanser, day cream (SPF 20), night cream, and eye cream. The regimen was evaluated in a randomized, double-blind, vehicle-controlled clinical trial. white women, 45-65 years old, with moderate facial photodamage (4-7 on a 0-9 grading scale), were randomized to use either the four active products or their vehicles daily for 16 weeks. At weeks 0, 2, 4, 8, 12, and 16, the blinded investigator graded clinical signs of aging, assessed irritation, and timed pinch recoil on the lateral side of the left eye. Half of the subjects in each group also had ultrasound imaging to assess skin density of the lateral canthus at weeks 8 and 16. Subjects completed questionnaires and were photographed. Out of 69 women who completed the study, 44 used the active products and 25 used vehicles. The active product group outperformed the vehicle group on all signs of aging by week 12 (P \.05). At week 16, significantly more active product users than vehicle users reached a 1-grade improvement in fine lines (91% vs 48%), wrinkles (55% vs 16%), skin laxity (98% vs 48%), pore size (64% vs 12%), dyschromia (86% vs 24%), sallowness (89% vs 24%), eyelid droopiness (86% vs 52%), periocular crepiness (89% vs 48%), and overall appearance (93% vs 72%). In addition, significantly more active product users than vehicle users showed a 2grade improvement in skin clarity (77% vs 20%), visual roughness (86% vs 32%), and tactile roughness (100% vs 84%). Pinch recoil rate decreased significantly more in the active group (18%) than in the vehicle group (8%) by week 16 (P \.05). Skin density in ultrasound images increased significantly in the active group but not in the vehicle group (P \ .05). All products were well tolerated by users. Clinical photographs showed improvements to fine lines, wrinkles, eyelid crepiness, and pigmentation. When used together, the new clinical strength, multimechanism skin care formulations are well tolerated and deliver significant antiaging benefits to photodamaged skin, well exceeding the effect of the vehicle.
Barbara A. Green, MS, NeoStrata Company, Inc, Princeton, NJ, United States; Brenda L. Edison, NeoStrata Company, Inc, Princeton, NJ, United States; Irina Brouda, NeoStrata Company, Inc, Princeton, NJ, United States; Ronni L. Weinkauf, PhD, NeoStrata Company, Inc, Princeton, NJ, United States Deep wrinkles and creases result from repetitive motion in combination with damage from sunlight and free radicals. These visual signs of aging can be mitigated with various dermal fillers and botulinum toxins for patients willing to undergo injectable therapies. A new amino acid (tyrosine) derivative was recently found to significantly build volume in the dermal matrix when applied topically. This new antiaging compound may provide an alternative treatment for those patients who are reluctant to use injectable therapies and/or are in a maintenance phase. Histologic examination of white forearm skin treated with the tyrosine derivative revealed increases in viable epidermal thickness, papillary dermal thickness, and staining for glycosaminoglycans (GAGs). A corresponding increase in skin thickness was measured using digital calipers. In a pilot clinical study, 17 women, 35-65 years of age, applied the tyrosine derivative, 2%, in serum followed by 1.25% in lightly occlusive cream to target lines and wrinkles on the face twice daily for 8 weeks. Subjects were photographed and completed self-assessment questionnaires. Photographs revealed noticeable decreases in deep crow’s feet, nasolabial folds, and glabellar lines. The subjects reported smoother skin (94%) and improved appearance (100%). Other known benefits of the tyrosine derivative include exfoliation and antioxidant effects. Application of a 2% cream for 2 weeks was shown to normalize and smooth the rough skin of lamellar ichthyosis. The tyrosine derivative also has a high oxygen radical absorbance capacity (ORAC value ¼ 5149), which markedly exceeds that of ascorbic acid (650) and N-acetyl cysteine (680), offering similar antioxidant potential as coffee berry (5700). The safety of this compound was assessed in a series of in vitro and clinical studies. The tyrosine derivative was found to be nonmutagenic in the Ames test and the chromosomal aberration test. It was found to be nonirritating, nonallergenic, and nonphotoallergenic on human skin, nonphototoxic in vitro, and nonirritating in an in vitro test for eye irritation. Skin penetration studies using the Franz cell diffusion model provided evidence of penetration via different types of vehicles. Studies with this novel tyrosine derivative indicate that it is well tolerated topically and can be used to help restore volume to the skin’s matrix, reducing the appearance of deep lines and wrinkles.
Commercial support: 100% sponsored by NeoStrata Company, Inc.
Commercial support: 100% sponsored by NeoStrata Company, Inc.
AB20
J AM ACAD DERMATOL
APRIL 2012
(Poster reference number 5577)
Marion Moers-Carpi, MD, Hautok und Hautok-cosmetics, M€ unchen, Germany; Antony Fulford-Smith, MBBS, Allergan Ltd. (GB), Marlow, United Kingdom; Kelvin Tan, MBBCh, Allergan Ltd. (GB), Marlow, United Kingdom Background: The prescribing information for all type A botulinum toxins clearly identifies that each has unique potency units that are specific and not interchangeable. Previously reported potency data has shown that batches of onabotulinumtoxin A and incobotulinumtoxin A are not equipotent when tested in the Allergan LD50 assay. The purpose of this study was to explore the relative efficacy of different labeled doses of these two type A botulinum toxins for the treatment of glabellar lines in a clinical setting. Study design: Patients with moderate/severe glabellar lines were randomized in an appropriately powered double blind, comparative study of either onabotulinumtoxin A (20 units) or incobotulinumtoxin A (30 units). At days 28, 84, 98, and 112, physicians rated the severity of glabellar lines at maximum contraction using the Facial Wrinkle Scale (FWS). The primary endpoint was the proportion of responders within each treatment group based on the injector’s rating of FWS at maximum contraction at day 28. Treatment response was defined as achievement of 1 point or greater improvement in FWS at maximum contraction. Physicians also assessed adverse events (AEs) at all follow-up visits. Results: A total of 224 patients were randomized, 89.3% female, 98.7% white with median age 45 years (range 20-65). The groups were well balanced for age, sex, race, and stratified by moderate and severe on the FWS. At the primary endpoint, day 28, the number of responders in the onabotulinumtoxin A (20 units) group was 108 (96%), compared to 106 responders (95%) in the incobotulinumtoxin A (30 units) group. The results for the two groups were statistically comparable at the doses used in this study. Injector ratings of FWS in the two groups at days 84, 98, and 112 demonstrated a trend in favor of onabotulinumtoxin A and therefore did not show statistical equivalence. Forty-two AEs were reported, 3 were considered related to study medication (1 in onabotulinumtoxin A [20 unit] group and 2 in incobotulinumtoxin A (30 unit) group). Most AEs were mild, no patients were withdrawn due to AEs and no serious AEs were reported. Conclusions: In this randomized controlled study of labeled doses of different type A botulinum toxins, 20 units of onabotulinumtoxin A was as effective as 30 units of incobotulinumtoxin A, despite a 50% difference in unit doses.
A novel fluorescent assay used to measure the absorption efficacy of a sonic applicator
(Poster reference number 5574)
Greg Peterson, PhD, Pacific Bioscience Lab, Bellevue, WA, United States; Emily Henes, Pacific Bioscience Labs, Bellevue, WA, United States; Katherine Ortblad, MPH, Pacific Bioscience Laboratories, Bellevue, WA, United States; Michael Kearney, Pacific Bioscience Labs, Bellevue, WA, United States; Nina Koski, Pacific Bioscience Labs, Bellevue, WA, United States; Robert Akridge, PhD, Pacific Bioscience Labs, Bellevue, WA, United States Background: Eye serums/creams are typically applied to the delicate skin around the eye area using a gentle tapping motion of the ring finger. A sonic applicator was invented to replace manual application by generating gentle sonic pulses that rapidly (but gently) massages serums/eye creams into outer most layers of the stratum corneum. In order to determine the efficacy of this technology, a novel fluorescent serum-dye assay was developed to assess the efficacy of sonic application. Methods: A single-visit study was conducted to assessed absorption by different application methods. In this study a noninvasive fluorescent serum dye method, as well as photographs, and image analysis were used. A fluorescent marker was mixed into an antiaging sea serum and applied to the lower eye area, both manually and with the sonic applicator. The same volume of the serum dye mixture (z50 L) was applied to lower area of both eyes. Participants were instructed to apply the serum dye mixture to the right lower eye area using their ring finger as they normally would at home, and to the left lower eye area using the sonic applicator. Immediately after application, the serum dye mixture was blotted twice with an absorbent tissue in a consistent and systematic way to remove excess serum remaining on the surface of the skin. Photographs were taken using a Visia CR camera. Results: Ultraviolet images revealed a disproportional amount of fluorescent marker remaining on the sonically applied eye area. The fluorescence remaining around the eye area after application was quantified by using image analysis software [Image J 1.43; NIH]. Results were then compared statistically using a paired t test. A statistically significant difference (P ¼ .003) was detected between the manual and sonic application. Conclusion: Photographs and Image J analysis confirm that sonic application using a fluorescent marker results in more absorption into the stratum corneum. Commercial support: Pacific Bioscience Laboratories.
Commercial support: Sponsored by Allergan. K. Tan and A. Fulford-Smith are employees of Allergan.
A new clinical strength, multimechanism skin care regimen for photodamaged skin: Results from a vehicle-controlled clinical trial
(Poster reference number 4929)
Barbara A. Green, MS, NeoStrata Company, Inc, Princeton, NJ, United States; Brenda L. Edison, NeoStrata Company, Inc, Princeton, NJ, United States; Irina Brouda, NeoStrata Company, Inc, Princeton, NJ, United States; Patricia K. Farris, MD, Department of Dermatology, Tulane University School of Medicine, New Orleans, LA, United States; Ronni L. Weinkauf, PhD, NeoStrata Company, Inc, Princeton, NJ, United States
A novel tyrosine amino acid derivative as a topical wrinkle filler
(Poster reference number 5296)
Skin aging is a multifaceted biologic process that cannot be addressed by any single skin care ingredient. A clinical strength skin care regimen that delivers over 35% active benefit ingredients (hydroxyacids, N-acetylglucosamine, retinol, peptides, antioxidants, and apple stem cell extract) was developed to provide antiaging benefits across all skin layers via multiple mechanisms. The regimen consists of a facial cleanser, day cream (SPF 20), night cream, and eye cream. The regimen was evaluated in a randomized, double-blind, vehicle-controlled clinical trial. white women, 45-65 years old, with moderate facial photodamage (4-7 on a 0-9 grading scale), were randomized to use either the four active products or their vehicles daily for 16 weeks. At weeks 0, 2, 4, 8, 12, and 16, the blinded investigator graded clinical signs of aging, assessed irritation, and timed pinch recoil on the lateral side of the left eye. Half of the subjects in each group also had ultrasound imaging to assess skin density of the lateral canthus at weeks 8 and 16. Subjects completed questionnaires and were photographed. Out of 69 women who completed the study, 44 used the active products and 25 used vehicles. The active product group outperformed the vehicle group on all signs of aging by week 12 (P \.05). At week 16, significantly more active product users than vehicle users reached a 1-grade improvement in fine lines (91% vs 48%), wrinkles (55% vs 16%), skin laxity (98% vs 48%), pore size (64% vs 12%), dyschromia (86% vs 24%), sallowness (89% vs 24%), eyelid droopiness (86% vs 52%), periocular crepiness (89% vs 48%), and overall appearance (93% vs 72%). In addition, significantly more active product users than vehicle users showed a 2grade improvement in skin clarity (77% vs 20%), visual roughness (86% vs 32%), and tactile roughness (100% vs 84%). Pinch recoil rate decreased significantly more in the active group (18%) than in the vehicle group (8%) by week 16 (P \.05). Skin density in ultrasound images increased significantly in the active group but not in the vehicle group (P \ .05). All products were well tolerated by users. Clinical photographs showed improvements to fine lines, wrinkles, eyelid crepiness, and pigmentation. When used together, the new clinical strength, multimechanism skin care formulations are well tolerated and deliver significant antiaging benefits to photodamaged skin, well exceeding the effect of the vehicle.
Barbara A. Green, MS, NeoStrata Company, Inc, Princeton, NJ, United States; Brenda L. Edison, NeoStrata Company, Inc, Princeton, NJ, United States; Irina Brouda, NeoStrata Company, Inc, Princeton, NJ, United States; Ronni L. Weinkauf, PhD, NeoStrata Company, Inc, Princeton, NJ, United States Deep wrinkles and creases result from repetitive motion in combination with damage from sunlight and free radicals. These visual signs of aging can be mitigated with various dermal fillers and botulinum toxins for patients willing to undergo injectable therapies. A new amino acid (tyrosine) derivative was recently found to significantly build volume in the dermal matrix when applied topically. This new antiaging compound may provide an alternative treatment for those patients who are reluctant to use injectable therapies and/or are in a maintenance phase. Histologic examination of white forearm skin treated with the tyrosine derivative revealed increases in viable epidermal thickness, papillary dermal thickness, and staining for glycosaminoglycans (GAGs). A corresponding increase in skin thickness was measured using digital calipers. In a pilot clinical study, 17 women, 35-65 years of age, applied the tyrosine derivative, 2%, in serum followed by 1.25% in lightly occlusive cream to target lines and wrinkles on the face twice daily for 8 weeks. Subjects were photographed and completed self-assessment questionnaires. Photographs revealed noticeable decreases in deep crow’s feet, nasolabial folds, and glabellar lines. The subjects reported smoother skin (94%) and improved appearance (100%). Other known benefits of the tyrosine derivative include exfoliation and antioxidant effects. Application of a 2% cream for 2 weeks was shown to normalize and smooth the rough skin of lamellar ichthyosis. The tyrosine derivative also has a high oxygen radical absorbance capacity (ORAC value ¼ 5149), which markedly exceeds that of ascorbic acid (650) and N-acetyl cysteine (680), offering similar antioxidant potential as coffee berry (5700). The safety of this compound was assessed in a series of in vitro and clinical studies. The tyrosine derivative was found to be nonmutagenic in the Ames test and the chromosomal aberration test. It was found to be nonirritating, nonallergenic, and nonphotoallergenic on human skin, nonphototoxic in vitro, and nonirritating in an in vitro test for eye irritation. Skin penetration studies using the Franz cell diffusion model provided evidence of penetration via different types of vehicles. Studies with this novel tyrosine derivative indicate that it is well tolerated topically and can be used to help restore volume to the skin’s matrix, reducing the appearance of deep lines and wrinkles.
Commercial support: 100% sponsored by NeoStrata Company, Inc.
Commercial support: 100% sponsored by NeoStrata Company, Inc.
AB20
J AM ACAD DERMATOL
APRIL 2012