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Immediate and long-term clinical benefits of a novel topical treatment for facial lines and wrinkles
P1610
P1612
Immediate and long-term clinical benefits of a novel topical treatment for facial lines and wrinkles Nathan Trookman, Colorado Springs Dermatology Clinic, Rocky Mountain Laser Center, P.C., Colorado Springs, CO, United States; Elizabeth Ho, SkinMedica, Inc., Carlsbad, CA, United States; Ronald Rizer, PhD, Thomas J. Stephens & Associates, Inc., Colorado Springs, CO, United States; Rosanne Ford, SkinMedica, Inc., Carlsbad, CA, United States; Vincent Gotz, PharmD, MS, SkinMedica, Inc., Carlsbad, CA, United States One of the most prominent signs of skin aging is the development of wrinkles caused by intrinsic and environmentally-induced aging processes. The resulting structural changes, such as a reduction in collagen and elastin, and the loss of hydration contribute to the appearance of lines and wrinkles. Facial areas associated with expression movement, such as the periocular and perioral areas, are especially vulnerable to wrinkle formation. As a result, it can be difficult to find a topical treatment that produces visible improvement in these areas. To address the challenge of treating expressive facial areas, a novel topical line treatment was formulated with multiple growth factors, antioxidants, and a collagen-building peptide, ingredients that have been shown to increase collagen levels and provide long-term benefits. To help provide immediate effects, hylauronic acidefilling spheres, which provide moisturization, and a muscle contraction-inhibiting peptide were also included. To evaluate the tolerance and efficacy of this treatment, a 12week single-center open-label study was conducted. Thirty-seven female subjects between 33 and 46 years of age with mild to moderate fine and coarse periocular wrinkles were enrolled; 35 completed the study. Subjects applied the product to their periocular and perioral wrinkles twice daily. Investigator assessments of fine and coarse periocular and perioral wrinkles, subject questionnaires, and digital photography and tolerability assessments were conducted at all visits (baseline, within 15 minutes of initial application, and weeks 4 and 12). Silicone replicas of the periocular areas were conducted at baseline, week 4, and week 12. Investigator assessments of both periocular and perioral wrinkles showed statistically significant improvements over baseline within 15 minutes of application and continued through weeks 4 and 12 (all P # .0003). Digital photography and profilometry analysis confirmed the significant improvements seen in periocular wrinkle investigator assessments. The line treatment was well tolerated and no adverse events were reported. In subject assessments, the novel line treatment was highly rated in product efficacy and performance. Overall, the results from this study demonstrate that this uniquely formulated line treatment was well tolerated and provided both immediate and long-term improvements in the appearance of fine and coarse wrinkles.
Skin biomarkers confirm the antioxidant activity of olive derivatives and yeast ferment filtrate Deborah Finlay, MD, The Procter & Gamble Company, Cincinnati, OH, United States; Akira Date, PhD, The Procter & Gamble Company, Cincinnati, OH, United States; Heather Matheny, MMSc, The Procter & Gamble Company, Cincinnati, OH, United States; Lisa Mullins, MMSc, The Procter & Gamble Company, Cincinnati, OH, United States Background: Reactive oxygen species (ROS) are considered to play important roles in the process of ultraviolet light (UV)-induced skin damage, skin photoaging, and melanogenesis. A family of enzymes and antioxidant proteins under control of the antioxidant response element (ARE) provide ideal biomarkers to monitor antioxidant activities in skin. The ARE family of proteins can protect against oxidative damage to cells not only by increasing endogenous antioxidant levels in cells but also by up-regulating proteins that monitor for and repair the damage caused by ROS.
Conclusions: Two olive oilebased materials affected antioxidant biomarkers, and therefore should enhance the ability of skin to protect against damage from UV and environmentally generated ROS. Further addition of yeast ferment filtrate (YFF) produced a synergistic effect on HO-1 and provides a compelling reason to further understand the complementary nature of these materials. Therefore, the antioxidant properties of olive oil derivatives and YFF provide powerful protection and repair for skin against the continual assault of UV and environmentally induced ROS.
Commercial support: 100% sponsored by SkinMedica, Inc.
Commercial support: 100% sponsored by P&G Beauty.
Objective: Determine the antioxidant effects of topically applied olive derivatives and yeast ferment filtrate (YFF) on antioxidant biomarkers (ARE and related proteins). Methods: In vitro human skin models, including skin keratinocytes, fibroblasts, skin equivalents, and explants, were treated with olive derivatives (olive oilederived fatty acids modified with PEG-7, olive oil blended with jojoba oil) and YFF. ARE was assayed using the ARE-32 reporter cell line (CXR-Biosciences). Cell type and tissue confirmation of ARE were confirmed via enzyme activity, such as HO-1, and mRNA by reverse transcriptase-polymerase chain reaction. Results: Antioxidant properties of the olive derivatives was confirmed by ARE expression. Also, HO-1 in primary keratinocytes and fibroblasts confirmed ARE activity in skin-specific cells. Interestingly, the ARE biomarker was unaffected by YFF; however, HO-1 confirmed antioxidant activity of this material in keratinocytes. HO-1 indicated a synergistic antioxidant effect of the combination of the PEGmodified olive oil fatty acids with YFF. In addition, these materials appear to reduce UV-generated ROS in both skin equivalent and skin explant systems.
P1611 Investigator global evaluations of efficacy with injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles Fredric Brandt, MD, private practice, Coral Gables, FL, United States
P1613
Methods: In this randomized, evaluator-blinded, parallel-group, multicenter clinical study, one to four treatment sessions of injectable PLLA or human collagen HC were given at 3-week intervals until optimal cosmetic correction of both NLFs was achieved. The follow-up phase consisted of posttreatment visits after the last treatment at week 3 and months 3, 6, 9, and 13. Eligible subjects received multiple bilateral injections into the left and right NLFs. Standardized photographs were taken at screening and all treatment and follow-up visits. IGE assessments were made in comparison to baseline (pretreatment) values using the first photograph as a reference. The treating investigator rated NLFs for global aesthetic improvement using the following scale (one composite score for both NLFs): 4, excellent improvement; 3, much improved; 2, improved; 1, no change; and 0, worse. Safety analyses were done on all subjects receiving $ 1 study treatment of either device. Results: Two hundred thirty-three subjects were randomized (n ¼ 116, injectable PLLA; n ¼ 117, HC). Based on the IGE, subjects treated with injectable PLLA and reporting scores of ‘‘overall improved’’ (improved, much improved, or excellent improvement) was [88% over the entire posttreatment follow-up period (100% at week 3). HC-treated subjects reported scores of ‘‘overall improved’’ from 95.7% at week 3 to 6.3% at month 13. Significant differences (P \.001) in IGE assessments were observed between injectable PLLA and HC groups at follow-up months 3, 6, 9, and 13. Overall, the incidence of product-related adverse events (AEs) was 20.7% among injectable PLLA-treated subjects and 35.9% in HC-treated subjects. Most AEs were mild or moderate in intensity; no product-related serious AEs were reported. Respective incidences of product-related application-site papules (\5 mm) and nodules ( $ 5 mm) were 8.6% and 6.9% for injectable PLLA and 3.4% and 6.0% for HC. Conclusions: In the injectable PLLA group, proportions of subjects with IGE scores of the ‘‘overall improved’’ remained above 88% over the 13-month follow-up period.
Comparison of stabilized retinol technology to glucosamine complex technology for antiaging benefits Tara Zedayko, MBBS, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Claude Saliou, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Curtis Cole, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Samantha Tucker-Samaras, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Warren Wallo, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States The volume of antiaging treatments available to patients continues to grow, and now more investigators are completing placebo-controlled, scientific clinical studies to verify their clinical benefits. The use of topical retinoids to reduce the signs of skin aging is well documented, and it has been shown that stabilized retinol diminishes many of these markers. In vitro studies have shown that retinol effects stimulation of collagen synthesis, reduction of matrix metalloproteinase levels, and induction of fibroblasts outgrowth. Also, long-term application of retinol at 0.04% in the upper arms reduced fine lines and provoked an accumulation of collagen in the papillary dermis. A double-blind, placebo-controlled, split-face study was conducted with an independent dermatologist to compare the ability of two different skin care technologies to deliver cutaneous benefits to photodamaged skin. A formulation containing 0.1% stabilized Retinol was compared with a formulation containing a glucosamine complex, and a placebo formulation containing no specific antiaging technology. Subjects were randomly assigned to two different formulas, and used the formulas once a day in the morning, over an 8-week period. Comparisons of the retinol formulation versus placebo and versus the glucosamine complex formulation included dermatologist assessment of fine and coarse wrinkling parameters, pigmentation parameters, firmness, and laxity parameters. By 4 weeks, improvement of the sites treated with retinol was statistically greater (P \.05) compared to both placebo and the glucosamine complex for fine lines and wrinkles, both on the cheeks and around the eyes, with higher significance by week 8. The retinol formulation also showed statistical superiority at 4 weeks for improvement of mottled and discrete pigmentation, as well as increased firming, all of which increased in significance by week 8. In this clinical study, a formulation containing retinol showed overall superior efficacy compared to a formulation containing a glucosamine complex for the treatment of the appearance of mild to moderate skin aging and photodamage.
Commercial support: Sponsored by Dermik Laboratories, a business of sanofiaventis U.S. LLC.
Commercial support: Sponsored by Johnson and Johnson Consumer Products Worldwide.
Background: Injectable poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic polymer device currently under review by the US Food and Drug Administration for cosmetic indications. Objective: To assess the efficacy of injectable PLLA compared with that of a commercially available human collagen (HC) in the treatment of nadolabial folds (NLFs) for 13 months using as a secondary efficacy endpoint the Investigator Global Evaluation (IGE) scale for global aesthetic improvement.
MARCH 2009
J AM ACAD DERMATOL
AB81
P1612
Immediate and long-term clinical benefits of a novel topical treatment for facial lines and wrinkles Nathan Trookman, Colorado Springs Dermatology Clinic, Rocky Mountain Laser Center, P.C., Colorado Springs, CO, United States; Elizabeth Ho, SkinMedica, Inc., Carlsbad, CA, United States; Ronald Rizer, PhD, Thomas J. Stephens & Associates, Inc., Colorado Springs, CO, United States; Rosanne Ford, SkinMedica, Inc., Carlsbad, CA, United States; Vincent Gotz, PharmD, MS, SkinMedica, Inc., Carlsbad, CA, United States One of the most prominent signs of skin aging is the development of wrinkles caused by intrinsic and environmentally-induced aging processes. The resulting structural changes, such as a reduction in collagen and elastin, and the loss of hydration contribute to the appearance of lines and wrinkles. Facial areas associated with expression movement, such as the periocular and perioral areas, are especially vulnerable to wrinkle formation. As a result, it can be difficult to find a topical treatment that produces visible improvement in these areas. To address the challenge of treating expressive facial areas, a novel topical line treatment was formulated with multiple growth factors, antioxidants, and a collagen-building peptide, ingredients that have been shown to increase collagen levels and provide long-term benefits. To help provide immediate effects, hylauronic acidefilling spheres, which provide moisturization, and a muscle contraction-inhibiting peptide were also included. To evaluate the tolerance and efficacy of this treatment, a 12week single-center open-label study was conducted. Thirty-seven female subjects between 33 and 46 years of age with mild to moderate fine and coarse periocular wrinkles were enrolled; 35 completed the study. Subjects applied the product to their periocular and perioral wrinkles twice daily. Investigator assessments of fine and coarse periocular and perioral wrinkles, subject questionnaires, and digital photography and tolerability assessments were conducted at all visits (baseline, within 15 minutes of initial application, and weeks 4 and 12). Silicone replicas of the periocular areas were conducted at baseline, week 4, and week 12. Investigator assessments of both periocular and perioral wrinkles showed statistically significant improvements over baseline within 15 minutes of application and continued through weeks 4 and 12 (all P # .0003). Digital photography and profilometry analysis confirmed the significant improvements seen in periocular wrinkle investigator assessments. The line treatment was well tolerated and no adverse events were reported. In subject assessments, the novel line treatment was highly rated in product efficacy and performance. Overall, the results from this study demonstrate that this uniquely formulated line treatment was well tolerated and provided both immediate and long-term improvements in the appearance of fine and coarse wrinkles.
Skin biomarkers confirm the antioxidant activity of olive derivatives and yeast ferment filtrate Deborah Finlay, MD, The Procter & Gamble Company, Cincinnati, OH, United States; Akira Date, PhD, The Procter & Gamble Company, Cincinnati, OH, United States; Heather Matheny, MMSc, The Procter & Gamble Company, Cincinnati, OH, United States; Lisa Mullins, MMSc, The Procter & Gamble Company, Cincinnati, OH, United States Background: Reactive oxygen species (ROS) are considered to play important roles in the process of ultraviolet light (UV)-induced skin damage, skin photoaging, and melanogenesis. A family of enzymes and antioxidant proteins under control of the antioxidant response element (ARE) provide ideal biomarkers to monitor antioxidant activities in skin. The ARE family of proteins can protect against oxidative damage to cells not only by increasing endogenous antioxidant levels in cells but also by up-regulating proteins that monitor for and repair the damage caused by ROS.
Conclusions: Two olive oilebased materials affected antioxidant biomarkers, and therefore should enhance the ability of skin to protect against damage from UV and environmentally generated ROS. Further addition of yeast ferment filtrate (YFF) produced a synergistic effect on HO-1 and provides a compelling reason to further understand the complementary nature of these materials. Therefore, the antioxidant properties of olive oil derivatives and YFF provide powerful protection and repair for skin against the continual assault of UV and environmentally induced ROS.
Commercial support: 100% sponsored by SkinMedica, Inc.
Commercial support: 100% sponsored by P&G Beauty.
Objective: Determine the antioxidant effects of topically applied olive derivatives and yeast ferment filtrate (YFF) on antioxidant biomarkers (ARE and related proteins). Methods: In vitro human skin models, including skin keratinocytes, fibroblasts, skin equivalents, and explants, were treated with olive derivatives (olive oilederived fatty acids modified with PEG-7, olive oil blended with jojoba oil) and YFF. ARE was assayed using the ARE-32 reporter cell line (CXR-Biosciences). Cell type and tissue confirmation of ARE were confirmed via enzyme activity, such as HO-1, and mRNA by reverse transcriptase-polymerase chain reaction. Results: Antioxidant properties of the olive derivatives was confirmed by ARE expression. Also, HO-1 in primary keratinocytes and fibroblasts confirmed ARE activity in skin-specific cells. Interestingly, the ARE biomarker was unaffected by YFF; however, HO-1 confirmed antioxidant activity of this material in keratinocytes. HO-1 indicated a synergistic antioxidant effect of the combination of the PEGmodified olive oil fatty acids with YFF. In addition, these materials appear to reduce UV-generated ROS in both skin equivalent and skin explant systems.
P1611 Investigator global evaluations of efficacy with injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles Fredric Brandt, MD, private practice, Coral Gables, FL, United States
P1613
Methods: In this randomized, evaluator-blinded, parallel-group, multicenter clinical study, one to four treatment sessions of injectable PLLA or human collagen HC were given at 3-week intervals until optimal cosmetic correction of both NLFs was achieved. The follow-up phase consisted of posttreatment visits after the last treatment at week 3 and months 3, 6, 9, and 13. Eligible subjects received multiple bilateral injections into the left and right NLFs. Standardized photographs were taken at screening and all treatment and follow-up visits. IGE assessments were made in comparison to baseline (pretreatment) values using the first photograph as a reference. The treating investigator rated NLFs for global aesthetic improvement using the following scale (one composite score for both NLFs): 4, excellent improvement; 3, much improved; 2, improved; 1, no change; and 0, worse. Safety analyses were done on all subjects receiving $ 1 study treatment of either device. Results: Two hundred thirty-three subjects were randomized (n ¼ 116, injectable PLLA; n ¼ 117, HC). Based on the IGE, subjects treated with injectable PLLA and reporting scores of ‘‘overall improved’’ (improved, much improved, or excellent improvement) was [88% over the entire posttreatment follow-up period (100% at week 3). HC-treated subjects reported scores of ‘‘overall improved’’ from 95.7% at week 3 to 6.3% at month 13. Significant differences (P \.001) in IGE assessments were observed between injectable PLLA and HC groups at follow-up months 3, 6, 9, and 13. Overall, the incidence of product-related adverse events (AEs) was 20.7% among injectable PLLA-treated subjects and 35.9% in HC-treated subjects. Most AEs were mild or moderate in intensity; no product-related serious AEs were reported. Respective incidences of product-related application-site papules (\5 mm) and nodules ( $ 5 mm) were 8.6% and 6.9% for injectable PLLA and 3.4% and 6.0% for HC. Conclusions: In the injectable PLLA group, proportions of subjects with IGE scores of the ‘‘overall improved’’ remained above 88% over the 13-month follow-up period.
Comparison of stabilized retinol technology to glucosamine complex technology for antiaging benefits Tara Zedayko, MBBS, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Claude Saliou, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Curtis Cole, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Samantha Tucker-Samaras, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States; Warren Wallo, PhD, Johnson and Johnson Consumer Products Worldwide, Skillman, NJ, United States The volume of antiaging treatments available to patients continues to grow, and now more investigators are completing placebo-controlled, scientific clinical studies to verify their clinical benefits. The use of topical retinoids to reduce the signs of skin aging is well documented, and it has been shown that stabilized retinol diminishes many of these markers. In vitro studies have shown that retinol effects stimulation of collagen synthesis, reduction of matrix metalloproteinase levels, and induction of fibroblasts outgrowth. Also, long-term application of retinol at 0.04% in the upper arms reduced fine lines and provoked an accumulation of collagen in the papillary dermis. A double-blind, placebo-controlled, split-face study was conducted with an independent dermatologist to compare the ability of two different skin care technologies to deliver cutaneous benefits to photodamaged skin. A formulation containing 0.1% stabilized Retinol was compared with a formulation containing a glucosamine complex, and a placebo formulation containing no specific antiaging technology. Subjects were randomly assigned to two different formulas, and used the formulas once a day in the morning, over an 8-week period. Comparisons of the retinol formulation versus placebo and versus the glucosamine complex formulation included dermatologist assessment of fine and coarse wrinkling parameters, pigmentation parameters, firmness, and laxity parameters. By 4 weeks, improvement of the sites treated with retinol was statistically greater (P \.05) compared to both placebo and the glucosamine complex for fine lines and wrinkles, both on the cheeks and around the eyes, with higher significance by week 8. The retinol formulation also showed statistical superiority at 4 weeks for improvement of mottled and discrete pigmentation, as well as increased firming, all of which increased in significance by week 8. In this clinical study, a formulation containing retinol showed overall superior efficacy compared to a formulation containing a glucosamine complex for the treatment of the appearance of mild to moderate skin aging and photodamage.
Commercial support: Sponsored by Dermik Laboratories, a business of sanofiaventis U.S. LLC.
Commercial support: Sponsored by Johnson and Johnson Consumer Products Worldwide.
Background: Injectable poly-L-lactic acid (PLLA) is a biodegradable, biocompatible, synthetic polymer device currently under review by the US Food and Drug Administration for cosmetic indications. Objective: To assess the efficacy of injectable PLLA compared with that of a commercially available human collagen (HC) in the treatment of nadolabial folds (NLFs) for 13 months using as a secondary efficacy endpoint the Investigator Global Evaluation (IGE) scale for global aesthetic improvement.
MARCH 2009
J AM ACAD DERMATOL
AB81