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A new 2-step topical line filler improves the appearance of glabellar lines, nasolabial folds, and crow's feet in a randomized, vehicle-controlled trial
P6806
P6689
A multicenter, double-masked, placebo-controlled study assessing patient satisfaction with bimatoprost ophthalmic solution 0.03% for increasing eyelash prominence Joel Cohen, MD, University of Colorado, Denver, CO, United States; Carrie Caulkins, PhD, Allergan, Inc, Irvine, CA, United States; Christine Somogyi, RN, Allergan, Inc, Irvine, CA, United States; Edwin Williams, MD, Titan Research and Development Group, Latham, NY, United States; Fredric Brandt, MD, Dermatology Research Institute, Coral Gables, FL, United States; Lawrence Green, MD, George Washington University, Washington, District of Columbia, United States; Ruth Tedaldi, MD, Dermatology Partners, Inc, Wellesley, MA, United States
A new 2-step topical line filler improves the appearance of glabellar lines, nasolabial folds, and crow’s feet in a randomized, vehicle-controlled trial 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; Lisa Buckley, 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
Objective: To determine patient satisfaction with bimatoprost ophthalmic solution 0.03% treatment for increasing eyelash prominence. Methods: This was a multicenter, double-masked, randomized, placebo-controlled study. A total of 88 patients were randomized in a 1:1 ratio to bimatoprost ophthalmic solution 0.03% (Allergan, Inc) or placebo. Scheduled follow-up visits were at weeks 4, 8, 12, and 16. The primary endpoint was patient satisfaction with their eyelashes, assessed on a 5-point scale (+2 ¼ very satisfied; -2 ¼ very unsatisfied) using item 3 of the validated 9-item Eyelash Satisfaction Questionnaire (ESQ-9). Secondary endpoints included eyelash prominence assessed by the investigator Global Eyelash Assessment (GEA), ESQ-9 total score, and patient satisfaction with treatment. Adverse events (AEs) were monitored throughout the study. Results: More patients treated with bimatoprost ophthalmic solution 0.03% were satisfied or very satisfied with their eyelashes than those treated with placebo at 16 weeks (67% vs 7%; P \.001). A 1-point improvement in GEA was reported by 72% and 19% of patients in bimatoprost ophthalmic solution 0.03% and placebo groups, respectively (P \.001). Intergroup difference was seen as early as week 8 and at all subsequent study visits. More patients in the bimatoprost ophthalmic solution 0.03% group were satisfied with eyelash length (P \ .001) as well as eyelash thickness/fullness (P \ .001), and were more likely to use and recommend treatment, compared with those in the placebo group. One patient in each group reported AEs possibly related to treatment (eye irritation, placebo group; itching, redness, and irritation of upper eyelids, bimatoprost ophthalmic solution 0.03% group). Both patients discontinued treatment. Conclusion: Significantly more patients using bimatoprost ophthalmic solution 0.03% for increasing eyelash prominence were satisfied with both eyelash appearance and treatment, compared with those using placebo. Treatment was well tolerated. 100% sponsored by Allergan, Inc
Facial wrinkles arise because of diminished production and increased breakdown of dermal matrix components, including collagen, glycosaminoglycans, and elastin, as a result of natural aging and photodamage. Injectable wrinkle fillers help temporarily reverse the appearance of wrinkles but are not without risks or discomfort. For those patients who prefer a topical alternative, a new 2-step topical line filler has been developed to target deep expression lines on the face. The tolerability and efficacy of the 2-step serum plus cream filler was tested for 16 weeks in women, 40 to 65 years of age, with moderate facial photodamage in target wrinkle areas (score 4-6 on a 0-9 scale) in a single-center, randomized, vehicle-controlled, clinical trial. Twice a day, subjects cleansed their faces and treated target wrinkle areas with filler serum or vehicle serum (step 1) and then with filler cream or vehicle cream (step 2). In addition, the entire face was treated with a vehicle day cream SPF 20 or vehicle night cream for all-over moisturization and sunscreen. Subjects were evaluated at weeks 0, 4, 8, 12, and 16. At each visit, a trained clinician graded glabellar lines, nasolabial folds, under eye wrinkles, and crow’s feet using a modified Griffiths’ scale (GS) from 0 (none) to 9 (severe) with 0.5-grade increments; graded nasolabial folds using a modified Wrinkle Severity Rating Scale (WSRS), a validated scale used to grade the effects of injectable wrinkle fillers on nasolabial folds, ranging from 1 (absent) to 5 (extreme) with 0.5-grade increments; timed pinch recoil of one under-eye area; and assessed skin irritation. Subjects’ faces were photographed, and subjects completed self-assessment questionnaires. Seventy women (47 filler group, 23 vehicle group) completed the study. The topical line filler was statistically superior (P \.05) to its vehicle in improving nasolabial folds (10.3% vs 0.9%) on the WSRS, in improving glabellar lines (7.7% vs 1.3%), crow’s feet (17.8% vs 7.9%), and under-eye wrinkles (20.3% vs 5.8%) on the GS, and in reducing pinch recoil time (10.1% vs 5.7%). Clinical photography and self-assessment scores confirmed improvement to targeted wrinkle areas. Both topical line filler and its vehicle were tolerated well. The 2-step topical line filler was well tolerated and effective for improving the appearance of deep expression lines in women with cutaneous photodamage and may be considered a topical alternative to injectable wrinkle fillers. 100% sponsored by NeoStrata Company, Inc.
P7129 A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of repeat treatments of crow’s feet lines and glabellar lines with onabotulinumtoxina Jean Carruthers, MD, University of British Columbia, Vancouver, BC, Canada; Alexander Rivkin, MD, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States; Christine Somogyi, RN, Allergan, Inc, Irvine, CA, United States; Elisabeth Lee, MPH, Allergan, Inc, Irvine, CA, United States; Frederick Beddingfield, III, MD, PhD, Allergan, Inc, Irvine, CA, United States; Lisa Donofrio, MD, Yale University School of Medicine, New Haven, CT, United States; Vince Bertucci, MD, University of Toronto, Woodbridge, ON, Canada Objective: To assess efficacy and safety of repeated onabotulinumtoxin A treatments of crow’s feet lines (CFL) with or without glabellar (GL) lines for up to 1 year.
P6605
Conclusion: Repeated onabotulinumtoxinA treatments of CFL alone or concurrently with GL are associated with significantly reduced CFL severity and significantly higher subject satisfaction and additional PROs. The safety profile was consistent with the approved GL indication.
A pilot study of a novel noninvasive topical under-eye contouring technology Arielle Kauvar, MD, New York Laser and Skin Care, New York, NY, United States; Barbara A. Gilchrest, MD, Boston University School of Medicine, Dermatology, Boston, MA, United States; Betty Yu, ScD, Living Proof, Cambridge, MA, United States; E. Victor Ross, MD, Scripps Clinic Carmel Valley, San Diego, CA, United States; Richard Rox Anderson, MD, Massachusetts General Hospital, Boston, MA, United States; Robert S. Langer, ScD, Massachusetts Institute of Technology, Boston, MA, United States; Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California, Sacramento, CA, United States Interest in facial rejuvenation is a growing trend both in the United States and worldwide. Botulinum toxin cosmetic procedures, for example, have increased by 621% over the past decade. Effective options for the lower eyelid, however, remain unmet. Common complaints among patients include the protrusion of the lower eyelid fat pads resulting in ‘‘malar bags’’ and the presence of rhytides. We have developed a novel flowable, skin contouring, polymer emulsion system that promises to provide a safe, noninvasive topical alternative to existing lower lid treatment modalities. The polymer technology evaluated here is activated immediately to form a breathable, immensely hydrating, invisible, elastic film that imparts natural skin aesthetics at the lower lid application site, while reducing the appearance of under-eye bags and rhytides. We report a pilot clinical study of 24 women between the ages of 40 and 65 years at 3 clinical test sites. Standardized 0 to 4 photonumeric scales for under-eye bags (UBs; grade 0 designates a continuous contour from the lower lid to the cheek and grade 4 describes severe protrusion of UB) and for rhytides (RH; grade 0 corresponds to no RH and grade 4 depicts severe RH) were used to quantify changes at the polymer application sites. The physicians’ assessment of the lower lid sites yielded baseline values of 2.6 6 0.62 and 2.7 6 0.57 for UB and for RH, respectively. Statistically significant (P \ .001) improvements in the scores were observed for the UB (1.7 6 0.81 and 1.6 6 0.96) and for RH (1.7 6 0.87 and 1.8 6 0.84) at 1 hour and 4 hours postapplication, respectively. These changes reflect a minimal improvement of 1 grade in the UB and the RH severity scores for 79% and 88% of the patients, respectively. Patients reported that the benefit present at 1 and 4 hours persisted until the product was removed at bedtime. Standardized photography of 8 patients, were similarly evaluated by 3 blinded physicians, yielding baseline scores of 2.7 6 0.85 (UB) and 1.9 6 0.86 (RH). Corresponding improvements at the 1- and 4-hour time points (P \ .001 compared with baseline) were observed for the UB (0.96 6 0.85 and 1.2 6 0.85, respectively), and for the RH (1.67 6 1.1 and 0.58 6 0.68, respectively). To date, to our knowledge, no other published scientific reports describe a topical technology yielding these remarkable and quantifiable lower lid aesthetic benefits.
100% is sponsored by Allergan, Inc
Supported by Living Proof.
Methods: This 1-year assessment was a double-blind, placebo-controlled (DBPC), 7-month study plus a DBPC, 5-month extension study. Subjects with moderate-tosevere CFL and GL (at maximum contraction using the Facial Wrinkle Scale with Photonumeric Guide [FWS]; 0 ¼ none to 3 ¼ severe) initially received 2 treatment cycles of onabotulinumtoxin A or placebo (PBO) 120 days apart. Subjects who had received onabotulinumtoxin A 24U (CFL only, n ¼ 227) or 44U (24U in CFL + 20U in GL, n ¼ 260) continued in their original treatment group, while PBO-treated subjects were rerandomized to onabotulinumtoxinA 44U (CFL+GL, n ¼ 101) or PBO (n ¼ 96) for up to 2 more treatment cycles. Retreatment in the 5-month extension per criteria: (1) $ 3 months since last treatment and (2) investigator-assessed CFL and GL of at least moderate severity. The primary efficacy endpoint was CFL FWS severity at maximum smile on day 30 after the first treatment (treatment 3) in the extension study (primary time point). Responders were those with a CFL severity rating of none or mild at maximum smile. Other endpoints were CFL severity at rest and maximum smile at all time points, GL severity, and patient-reported outcomes (PROs), including Subject’s Global Assessment of Change in CFL (SGA-CFL). Adverse events (AEs) were monitored. Results: 684 subjects entered the extension study. CFL responder rates (RRs) were significantly greater in the onabotulinumtoxin Aetreated groups (24U CFL: 56.5%; 44U CFL+GL: 63.6%; PBO: 1.1%; P \.001). RRs on most PROs at day 30 favored the 44U CFL+GL group over the 24U CFL group. The proportions reporting very much or much improved on the SGA-CFL were significantly higher in onabotulinumtoxinA groups (CFL: 56.5%; CFL+GL: 59.6%; PBO: 5.3%; P \.001). Subjects reporting very satisfied or satisfied with appearance at primary time point were 52.5%, 58.3%, and 7.5% in CFL, CFL+GL, and PBO groups (P\.001). The incidence of AEs did not differ significantly among groups; most AEs were mild or moderate. No subjects discontinued because of AEs.
AB20
J AM ACAD DERMATOL
APRIL 2013
P6689
A multicenter, double-masked, placebo-controlled study assessing patient satisfaction with bimatoprost ophthalmic solution 0.03% for increasing eyelash prominence Joel Cohen, MD, University of Colorado, Denver, CO, United States; Carrie Caulkins, PhD, Allergan, Inc, Irvine, CA, United States; Christine Somogyi, RN, Allergan, Inc, Irvine, CA, United States; Edwin Williams, MD, Titan Research and Development Group, Latham, NY, United States; Fredric Brandt, MD, Dermatology Research Institute, Coral Gables, FL, United States; Lawrence Green, MD, George Washington University, Washington, District of Columbia, United States; Ruth Tedaldi, MD, Dermatology Partners, Inc, Wellesley, MA, United States
A new 2-step topical line filler improves the appearance of glabellar lines, nasolabial folds, and crow’s feet in a randomized, vehicle-controlled trial 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; Lisa Buckley, 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
Objective: To determine patient satisfaction with bimatoprost ophthalmic solution 0.03% treatment for increasing eyelash prominence. Methods: This was a multicenter, double-masked, randomized, placebo-controlled study. A total of 88 patients were randomized in a 1:1 ratio to bimatoprost ophthalmic solution 0.03% (Allergan, Inc) or placebo. Scheduled follow-up visits were at weeks 4, 8, 12, and 16. The primary endpoint was patient satisfaction with their eyelashes, assessed on a 5-point scale (+2 ¼ very satisfied; -2 ¼ very unsatisfied) using item 3 of the validated 9-item Eyelash Satisfaction Questionnaire (ESQ-9). Secondary endpoints included eyelash prominence assessed by the investigator Global Eyelash Assessment (GEA), ESQ-9 total score, and patient satisfaction with treatment. Adverse events (AEs) were monitored throughout the study. Results: More patients treated with bimatoprost ophthalmic solution 0.03% were satisfied or very satisfied with their eyelashes than those treated with placebo at 16 weeks (67% vs 7%; P \.001). A 1-point improvement in GEA was reported by 72% and 19% of patients in bimatoprost ophthalmic solution 0.03% and placebo groups, respectively (P \.001). Intergroup difference was seen as early as week 8 and at all subsequent study visits. More patients in the bimatoprost ophthalmic solution 0.03% group were satisfied with eyelash length (P \ .001) as well as eyelash thickness/fullness (P \ .001), and were more likely to use and recommend treatment, compared with those in the placebo group. One patient in each group reported AEs possibly related to treatment (eye irritation, placebo group; itching, redness, and irritation of upper eyelids, bimatoprost ophthalmic solution 0.03% group). Both patients discontinued treatment. Conclusion: Significantly more patients using bimatoprost ophthalmic solution 0.03% for increasing eyelash prominence were satisfied with both eyelash appearance and treatment, compared with those using placebo. Treatment was well tolerated. 100% sponsored by Allergan, Inc
Facial wrinkles arise because of diminished production and increased breakdown of dermal matrix components, including collagen, glycosaminoglycans, and elastin, as a result of natural aging and photodamage. Injectable wrinkle fillers help temporarily reverse the appearance of wrinkles but are not without risks or discomfort. For those patients who prefer a topical alternative, a new 2-step topical line filler has been developed to target deep expression lines on the face. The tolerability and efficacy of the 2-step serum plus cream filler was tested for 16 weeks in women, 40 to 65 years of age, with moderate facial photodamage in target wrinkle areas (score 4-6 on a 0-9 scale) in a single-center, randomized, vehicle-controlled, clinical trial. Twice a day, subjects cleansed their faces and treated target wrinkle areas with filler serum or vehicle serum (step 1) and then with filler cream or vehicle cream (step 2). In addition, the entire face was treated with a vehicle day cream SPF 20 or vehicle night cream for all-over moisturization and sunscreen. Subjects were evaluated at weeks 0, 4, 8, 12, and 16. At each visit, a trained clinician graded glabellar lines, nasolabial folds, under eye wrinkles, and crow’s feet using a modified Griffiths’ scale (GS) from 0 (none) to 9 (severe) with 0.5-grade increments; graded nasolabial folds using a modified Wrinkle Severity Rating Scale (WSRS), a validated scale used to grade the effects of injectable wrinkle fillers on nasolabial folds, ranging from 1 (absent) to 5 (extreme) with 0.5-grade increments; timed pinch recoil of one under-eye area; and assessed skin irritation. Subjects’ faces were photographed, and subjects completed self-assessment questionnaires. Seventy women (47 filler group, 23 vehicle group) completed the study. The topical line filler was statistically superior (P \.05) to its vehicle in improving nasolabial folds (10.3% vs 0.9%) on the WSRS, in improving glabellar lines (7.7% vs 1.3%), crow’s feet (17.8% vs 7.9%), and under-eye wrinkles (20.3% vs 5.8%) on the GS, and in reducing pinch recoil time (10.1% vs 5.7%). Clinical photography and self-assessment scores confirmed improvement to targeted wrinkle areas. Both topical line filler and its vehicle were tolerated well. The 2-step topical line filler was well tolerated and effective for improving the appearance of deep expression lines in women with cutaneous photodamage and may be considered a topical alternative to injectable wrinkle fillers. 100% sponsored by NeoStrata Company, Inc.
P7129 A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of repeat treatments of crow’s feet lines and glabellar lines with onabotulinumtoxina Jean Carruthers, MD, University of British Columbia, Vancouver, BC, Canada; Alexander Rivkin, MD, David Geffen School of Medicine, UCLA, Los Angeles, CA, United States; Christine Somogyi, RN, Allergan, Inc, Irvine, CA, United States; Elisabeth Lee, MPH, Allergan, Inc, Irvine, CA, United States; Frederick Beddingfield, III, MD, PhD, Allergan, Inc, Irvine, CA, United States; Lisa Donofrio, MD, Yale University School of Medicine, New Haven, CT, United States; Vince Bertucci, MD, University of Toronto, Woodbridge, ON, Canada Objective: To assess efficacy and safety of repeated onabotulinumtoxin A treatments of crow’s feet lines (CFL) with or without glabellar (GL) lines for up to 1 year.
P6605
Conclusion: Repeated onabotulinumtoxinA treatments of CFL alone or concurrently with GL are associated with significantly reduced CFL severity and significantly higher subject satisfaction and additional PROs. The safety profile was consistent with the approved GL indication.
A pilot study of a novel noninvasive topical under-eye contouring technology Arielle Kauvar, MD, New York Laser and Skin Care, New York, NY, United States; Barbara A. Gilchrest, MD, Boston University School of Medicine, Dermatology, Boston, MA, United States; Betty Yu, ScD, Living Proof, Cambridge, MA, United States; E. Victor Ross, MD, Scripps Clinic Carmel Valley, San Diego, CA, United States; Richard Rox Anderson, MD, Massachusetts General Hospital, Boston, MA, United States; Robert S. Langer, ScD, Massachusetts Institute of Technology, Boston, MA, United States; Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California, Sacramento, CA, United States Interest in facial rejuvenation is a growing trend both in the United States and worldwide. Botulinum toxin cosmetic procedures, for example, have increased by 621% over the past decade. Effective options for the lower eyelid, however, remain unmet. Common complaints among patients include the protrusion of the lower eyelid fat pads resulting in ‘‘malar bags’’ and the presence of rhytides. We have developed a novel flowable, skin contouring, polymer emulsion system that promises to provide a safe, noninvasive topical alternative to existing lower lid treatment modalities. The polymer technology evaluated here is activated immediately to form a breathable, immensely hydrating, invisible, elastic film that imparts natural skin aesthetics at the lower lid application site, while reducing the appearance of under-eye bags and rhytides. We report a pilot clinical study of 24 women between the ages of 40 and 65 years at 3 clinical test sites. Standardized 0 to 4 photonumeric scales for under-eye bags (UBs; grade 0 designates a continuous contour from the lower lid to the cheek and grade 4 describes severe protrusion of UB) and for rhytides (RH; grade 0 corresponds to no RH and grade 4 depicts severe RH) were used to quantify changes at the polymer application sites. The physicians’ assessment of the lower lid sites yielded baseline values of 2.6 6 0.62 and 2.7 6 0.57 for UB and for RH, respectively. Statistically significant (P \ .001) improvements in the scores were observed for the UB (1.7 6 0.81 and 1.6 6 0.96) and for RH (1.7 6 0.87 and 1.8 6 0.84) at 1 hour and 4 hours postapplication, respectively. These changes reflect a minimal improvement of 1 grade in the UB and the RH severity scores for 79% and 88% of the patients, respectively. Patients reported that the benefit present at 1 and 4 hours persisted until the product was removed at bedtime. Standardized photography of 8 patients, were similarly evaluated by 3 blinded physicians, yielding baseline scores of 2.7 6 0.85 (UB) and 1.9 6 0.86 (RH). Corresponding improvements at the 1- and 4-hour time points (P \ .001 compared with baseline) were observed for the UB (0.96 6 0.85 and 1.2 6 0.85, respectively), and for the RH (1.67 6 1.1 and 0.58 6 0.68, respectively). To date, to our knowledge, no other published scientific reports describe a topical technology yielding these remarkable and quantifiable lower lid aesthetic benefits.
100% is sponsored by Allergan, Inc
Supported by Living Proof.
Methods: This 1-year assessment was a double-blind, placebo-controlled (DBPC), 7-month study plus a DBPC, 5-month extension study. Subjects with moderate-tosevere CFL and GL (at maximum contraction using the Facial Wrinkle Scale with Photonumeric Guide [FWS]; 0 ¼ none to 3 ¼ severe) initially received 2 treatment cycles of onabotulinumtoxin A or placebo (PBO) 120 days apart. Subjects who had received onabotulinumtoxin A 24U (CFL only, n ¼ 227) or 44U (24U in CFL + 20U in GL, n ¼ 260) continued in their original treatment group, while PBO-treated subjects were rerandomized to onabotulinumtoxinA 44U (CFL+GL, n ¼ 101) or PBO (n ¼ 96) for up to 2 more treatment cycles. Retreatment in the 5-month extension per criteria: (1) $ 3 months since last treatment and (2) investigator-assessed CFL and GL of at least moderate severity. The primary efficacy endpoint was CFL FWS severity at maximum smile on day 30 after the first treatment (treatment 3) in the extension study (primary time point). Responders were those with a CFL severity rating of none or mild at maximum smile. Other endpoints were CFL severity at rest and maximum smile at all time points, GL severity, and patient-reported outcomes (PROs), including Subject’s Global Assessment of Change in CFL (SGA-CFL). Adverse events (AEs) were monitored. Results: 684 subjects entered the extension study. CFL responder rates (RRs) were significantly greater in the onabotulinumtoxin Aetreated groups (24U CFL: 56.5%; 44U CFL+GL: 63.6%; PBO: 1.1%; P \.001). RRs on most PROs at day 30 favored the 44U CFL+GL group over the 24U CFL group. The proportions reporting very much or much improved on the SGA-CFL were significantly higher in onabotulinumtoxinA groups (CFL: 56.5%; CFL+GL: 59.6%; PBO: 5.3%; P \.001). Subjects reporting very satisfied or satisfied with appearance at primary time point were 52.5%, 58.3%, and 7.5% in CFL, CFL+GL, and PBO groups (P\.001). The incidence of AEs did not differ significantly among groups; most AEs were mild or moderate. No subjects discontinued because of AEs.
AB20
J AM ACAD DERMATOL
APRIL 2013