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Reduced volume of a novel hyaluronic acid dermal filler required for optimal correction of nasolabial folds compared to nonanimal stabilized hyaluronic acid
treatment. The patient was hospitalized for this event, which occurred during treatment cycle five and resolved after 32 days. The overall incidence of TEAEs and related events remained relatively constant or decreased over repeat cycles. The proportion of female patients (91% of study population) experiencing TEAEs decreased from 35% at cycle one to 26% at cycle eight for patients in the fixed-dose group, and from 35% at cycle one to 12% at cycle four for patients in the variabledose group. The most frequently reported AEs were nasopharyngitis (12% of patients), headache (7%), upper respiratory tract infection (6%), and sinusitis (6%). No clinically significant mean changes from baseline in vital signs (systolic and diastolic blood pressures and heart and respiratory rates) were observed. Rates of total TEAEs around the eyes ranged from 2% to 9%, depending on sex and fixed versus variable dosing. The most commonly reported AEs around the eyes were eyelid ptosis (2% of patients), eyelid edema (1%), and dry eye (1/%). A total of 40 ptosis events were reported in 37 patients; none was judged severe, and nearly half (47.5%; 19 of 40) resolved within 3 weeks. The number of ptosis events reported declined with successive cycles: cycle one, 13 events; cycles two and three, seven events each; cycles four and five, six events each; and cycle eight, one event. The incidence of ocular events overall and ptosis specifically did not appear to be doserelated. Conclusions: Multiple cycles of treatment with fixed (50 U) or variable (50 to 80 U) dosing of BoNT-A are well tolerated. There was no evidence of cumulative safety issues, because the incidence of AEs remained relatively constant or decreased over repeated treatment cycles.The information in this abstract is based on an interim analysis of study data. That analysis includes safety data collected through May 31, 2008. An original report of data collected through March 31, 2007, is in press with the Journal of the American Academy of Dermatology. Compared with the article in press at the Journal of the American Academy of Dermatology, this report in Aesthetic Surgery Journal includes data from nearly double the number of subjects (1414 compared with 768, respectively). It also includes variable-dosing safety data not found in the earlier report, because no patients from the variable-dosing study had entered the extension study at the time of the earlier analysis. Commercial support: None identified.
P3409 Safety and efficacy of a novel hyaluronic acid dermal filler for the correction of nasolabial folds Gary D. Monheit, MD, Total Skin and Beauty Dermatology Center, Birmingham, AL, United States; David J. Goldberg, MD, JD, Skin Laser & Surgery Specialists of New York & New Jersey, New York, NY, United States; Mitchel Goldman, MD, Dermatology/Cosmetic Laser Associates of La Jolla, La Jolla, CA, United States; Rhoda S. Narins, MD, Dermatology Surgery and Laser Center, White Plains, NY, United States Rationale and goal: Dermal Gel Extra (DGE) is a next-generation hyaluronic acid (HA)ebased dermal filler that contains 0.3% lidocaine. The objective of this study was to evaluate the safety and efficacy of DGE compared to nonanimal stabilized HA (NASHA) for the correction of nasolabial folds (NLFs). Methods: In a randomized, subject- and evaluator-blinded, multicenter study, 140 patients with moderate to deep NLFs were treated with DGE and NASHA in a splitface design. The extent of NLF wrinkle was determined by blinded evaluators before treatment (baseline) using the 6-point Genzyme grading scale. At the initial visit, and at up to two touch-up visits, patients were injected with sufficient product to achieve optimal correction. Efficacy for wrinkle correction was measured by blinded evaluators at months 1, 2, 4, 6, and 9 after the date of optimal correction (DOC). Pain during treatment and 15 and 30minutes postinjection was evaluated by the patients using a 100-mm visual analog scale (VAS). Satisfaction with the aesthetic results was assessed by the patients and investigators at months six and nine using a Global Assessment of Satisfaction scale. Adverse events were reported by patients in diaries and monitored by investigators throughout the study period. Results: The improvements in wrinkle scores from baseline to all timepoints after DOC were similar for DGE and NASHA. Patients reported significantly less pain with DGE than with NASHA during treatment (mean [6 SD] VAS scores of 23.2 [6 20.3] and 48.9 [6 26.0], respectively; P \.0001). Pain decreased at 15 and 30minutes postinjection for both treatments, with patients continuing to experience significantly less pain with DGE than with NASHA (P \.0001). Approximately 70% of patients assessed their aesthetic results as ‘‘much better’’ or ‘‘better’’ at months six and nine after DOC compared to baseline. Satisfaction with aesthetic outcome was similar for both products. The most frequently reported adverse events for DGE and NASHA were skin reactions at injection sites, which were generally mild to moderate in severity. Conclusions: DGE was as effective as NASHA for NLF correction at 9 months, with significantly less injection site pain experienced during treatment. Both treatments received high satisfaction ratings from patients and investigators and were well tolerated. Commercial support: Sponsored by Mentor, Genzyme, and Johnson & Johnson.
P3408 Long-term utility and safety of a novel collagen dermal filler, dermicolP35, in nonsurgical rhinoplasty Daniel Cassuto, MD, University of Catania, Milano, Lombardy, Italy Objectives: As cosmetic procedures become more common, people with congenital nasal defects or those acquired from other causes, such as trauma, oncologic surgery, aesthetic surgery complications, accidents, etc are increasingly looking for ways in which to correct these problems with procedures that are safe and longlasting, without initiating added trauma. In the last few years, the use of injectable dermal fillers has steadily grown because of their relatively low risk for adverse events, the option of reversing or correction if necessary, the rapidity with which results can be observed, and durability of these effects. The objective of this study was to evaluate the effectiveness and duration of rhinoplasty performed with Dermicol-P35 filler, a novel porcine collagen filler cross-linked with patented Glymatrix technology. Methods: Patients—A total of 14 patients $ 18 years of age needing nasal correction were enrolled. Patients with a history of sensitivity to porcine- or bovine-based products, a history of bleeding, active skin disease, or use of dermal filler within the previous 6 months were excluded. Of the 14 patients, 10 were female (4 skin type 2; 6 skin type 3) and four male (4 skin type 3) ranging from 23 to 63 years (mean 42 years) of age. The etiology list included trauma (7), basal cell carcinoma (3), congenital defects (2), and rhinoplasty (2). Treatment—The number of sessions needed for optimal correction was determined based on patients’ satisfaction after each session. If necessary, the filler was molded manually immediately after injection to ensure an even correction. Patients were injected with Dermicol-P35 27G filler using 10% lidocaine cream as a local anesthetic. Endpoints—The primary endpoint was patient satisfaction on a scale from 1 (not satisfied) to 5 (very satisfied). Photographic evidence was obtained before treatment (visit 1), immediately after treatment (visit 1), and at all subsequent visits. The duration of effect was also recorded. Adverse events were monitored at all time points. At the time of submission, patients were followed for 4 to 18 months. Results: The average patient satisfaction score was 4.6 with no patient scoring less than 4. Nine patients needed just one session and the other five needed two sessions. There were no adverse events reported by any patient either immediately after the procedure or during the follow-up period. At the time of submission, patients were followed for up to 18 months (mean, 9.4) without loss of efficacy. Conclusions: Both patient and physician satisfaction were high with the use of Dermicol-P35 27G dermal filler for nonsurgical corrective rhinoplasty. On average, the effects lasted at least 9.4 months. The procedure and the filler were well tolerated with no reports of adverse events. Commercial support: Preparation and printing costs sponsored by Ortho Dermatologics.
MARCH 2010
P3410 Reduced volume of a novel hyaluronic acid dermal filler required for optimal correction of nasolabial folds compared to nonanimal stabilized hyaluronic acid Gary D. Monheit, MD, Total Skin and Beauty Derm Center, Birmingham, AL, United States; Leslie Baumann, MD, University of Miami Cosmetic Center, Miami Beach, FL, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Mitchel Goldman, MD, Dermatology/Cosmetic Laser Associates of La Jolla, La Jolla, CA, United States Rationale and goal: Dermal Gel Extra (DGE) is a new hyaluronic acid (HA) dermal filler. The aim of this analysis was to compare the volume of product required for optimal correction during a clinical study designed to evaluate the safety and effectiveness of DGE compared to nonanimal stabilized HA (NASHA) in patients undergoing correction of nasolabial folds (NLFs). Methods: In this randomized, double-blinded study, patients were injected for optimal correction with DGE and NASHA in opposing NLFs using a split-face design. Up to two touch-up injections were administered at follow-up visits to achieve optimal correction. The volume of product injected was recorded at the initial treatment and at each of the two potential touch-up treatments. Wrinkle scores from baseline through 9 months were evaluated by blinded evaluators using the 6-point Genzyme grading scale. Patients were monitored for adverse events throughout the study period. Results: The 140 patients who participated in this study had moderate to deep NLFs before treatment. Efficacy for NLF correction, as measured by change in wrinkle scores, was similar for both products throughout the 9-month study period. The volume of DGE injected to achieve optimal correction at the initial visit was significantly less than the volume of NASHA (mean [6 SD] volume of 0.88 [6 0.22] mL and 0.97 [6 0.29] mL, respectively; P \.0001). The majority (55%) of NLFs treated with DGE were injected with \1.0mL of product, compared to only 34% of NLFs treated with NASHA. In addition, the number of touch-ups (range, 0-2) required for optimal correction with DGE was significantly less than with NASHA (mean [6 SD] number of touch-ups of 0.76 [6 0.77] and 0.90 [6 0.79], respectively; P ¼.0052). Both dermal fillers were well tolerated, and adverse events were typically mild and transient. Conclusions: Significantly less volume of DGE was required to achieve optimal NLF correction compared to NASHA. More DGE-treated NLFs than NASHA-treated NLFs reached optimal correction with \1.0mL of product. Furthermore, fewer touch-ups were required with DGE than with NASHA. These data demonstrate the efficacy and utility of DGE for NLF correction. Commercial support: Sponsored by Mentor, Genzyme, and Johnson & Johnson.
J AM ACAD DERMATOL
AB143
P3409 Safety and efficacy of a novel hyaluronic acid dermal filler for the correction of nasolabial folds Gary D. Monheit, MD, Total Skin and Beauty Dermatology Center, Birmingham, AL, United States; David J. Goldberg, MD, JD, Skin Laser & Surgery Specialists of New York & New Jersey, New York, NY, United States; Mitchel Goldman, MD, Dermatology/Cosmetic Laser Associates of La Jolla, La Jolla, CA, United States; Rhoda S. Narins, MD, Dermatology Surgery and Laser Center, White Plains, NY, United States Rationale and goal: Dermal Gel Extra (DGE) is a next-generation hyaluronic acid (HA)ebased dermal filler that contains 0.3% lidocaine. The objective of this study was to evaluate the safety and efficacy of DGE compared to nonanimal stabilized HA (NASHA) for the correction of nasolabial folds (NLFs). Methods: In a randomized, subject- and evaluator-blinded, multicenter study, 140 patients with moderate to deep NLFs were treated with DGE and NASHA in a splitface design. The extent of NLF wrinkle was determined by blinded evaluators before treatment (baseline) using the 6-point Genzyme grading scale. At the initial visit, and at up to two touch-up visits, patients were injected with sufficient product to achieve optimal correction. Efficacy for wrinkle correction was measured by blinded evaluators at months 1, 2, 4, 6, and 9 after the date of optimal correction (DOC). Pain during treatment and 15 and 30minutes postinjection was evaluated by the patients using a 100-mm visual analog scale (VAS). Satisfaction with the aesthetic results was assessed by the patients and investigators at months six and nine using a Global Assessment of Satisfaction scale. Adverse events were reported by patients in diaries and monitored by investigators throughout the study period. Results: The improvements in wrinkle scores from baseline to all timepoints after DOC were similar for DGE and NASHA. Patients reported significantly less pain with DGE than with NASHA during treatment (mean [6 SD] VAS scores of 23.2 [6 20.3] and 48.9 [6 26.0], respectively; P \.0001). Pain decreased at 15 and 30minutes postinjection for both treatments, with patients continuing to experience significantly less pain with DGE than with NASHA (P \.0001). Approximately 70% of patients assessed their aesthetic results as ‘‘much better’’ or ‘‘better’’ at months six and nine after DOC compared to baseline. Satisfaction with aesthetic outcome was similar for both products. The most frequently reported adverse events for DGE and NASHA were skin reactions at injection sites, which were generally mild to moderate in severity. Conclusions: DGE was as effective as NASHA for NLF correction at 9 months, with significantly less injection site pain experienced during treatment. Both treatments received high satisfaction ratings from patients and investigators and were well tolerated. Commercial support: Sponsored by Mentor, Genzyme, and Johnson & Johnson.
P3408 Long-term utility and safety of a novel collagen dermal filler, dermicolP35, in nonsurgical rhinoplasty Daniel Cassuto, MD, University of Catania, Milano, Lombardy, Italy Objectives: As cosmetic procedures become more common, people with congenital nasal defects or those acquired from other causes, such as trauma, oncologic surgery, aesthetic surgery complications, accidents, etc are increasingly looking for ways in which to correct these problems with procedures that are safe and longlasting, without initiating added trauma. In the last few years, the use of injectable dermal fillers has steadily grown because of their relatively low risk for adverse events, the option of reversing or correction if necessary, the rapidity with which results can be observed, and durability of these effects. The objective of this study was to evaluate the effectiveness and duration of rhinoplasty performed with Dermicol-P35 filler, a novel porcine collagen filler cross-linked with patented Glymatrix technology. Methods: Patients—A total of 14 patients $ 18 years of age needing nasal correction were enrolled. Patients with a history of sensitivity to porcine- or bovine-based products, a history of bleeding, active skin disease, or use of dermal filler within the previous 6 months were excluded. Of the 14 patients, 10 were female (4 skin type 2; 6 skin type 3) and four male (4 skin type 3) ranging from 23 to 63 years (mean 42 years) of age. The etiology list included trauma (7), basal cell carcinoma (3), congenital defects (2), and rhinoplasty (2). Treatment—The number of sessions needed for optimal correction was determined based on patients’ satisfaction after each session. If necessary, the filler was molded manually immediately after injection to ensure an even correction. Patients were injected with Dermicol-P35 27G filler using 10% lidocaine cream as a local anesthetic. Endpoints—The primary endpoint was patient satisfaction on a scale from 1 (not satisfied) to 5 (very satisfied). Photographic evidence was obtained before treatment (visit 1), immediately after treatment (visit 1), and at all subsequent visits. The duration of effect was also recorded. Adverse events were monitored at all time points. At the time of submission, patients were followed for 4 to 18 months. Results: The average patient satisfaction score was 4.6 with no patient scoring less than 4. Nine patients needed just one session and the other five needed two sessions. There were no adverse events reported by any patient either immediately after the procedure or during the follow-up period. At the time of submission, patients were followed for up to 18 months (mean, 9.4) without loss of efficacy. Conclusions: Both patient and physician satisfaction were high with the use of Dermicol-P35 27G dermal filler for nonsurgical corrective rhinoplasty. On average, the effects lasted at least 9.4 months. The procedure and the filler were well tolerated with no reports of adverse events. Commercial support: Preparation and printing costs sponsored by Ortho Dermatologics.
MARCH 2010
P3410 Reduced volume of a novel hyaluronic acid dermal filler required for optimal correction of nasolabial folds compared to nonanimal stabilized hyaluronic acid Gary D. Monheit, MD, Total Skin and Beauty Derm Center, Birmingham, AL, United States; Leslie Baumann, MD, University of Miami Cosmetic Center, Miami Beach, FL, United States; Michael Gold, MD, Tennessee Clinical Research Center, Nashville, TN, United States; Mitchel Goldman, MD, Dermatology/Cosmetic Laser Associates of La Jolla, La Jolla, CA, United States Rationale and goal: Dermal Gel Extra (DGE) is a new hyaluronic acid (HA) dermal filler. The aim of this analysis was to compare the volume of product required for optimal correction during a clinical study designed to evaluate the safety and effectiveness of DGE compared to nonanimal stabilized HA (NASHA) in patients undergoing correction of nasolabial folds (NLFs). Methods: In this randomized, double-blinded study, patients were injected for optimal correction with DGE and NASHA in opposing NLFs using a split-face design. Up to two touch-up injections were administered at follow-up visits to achieve optimal correction. The volume of product injected was recorded at the initial treatment and at each of the two potential touch-up treatments. Wrinkle scores from baseline through 9 months were evaluated by blinded evaluators using the 6-point Genzyme grading scale. Patients were monitored for adverse events throughout the study period. Results: The 140 patients who participated in this study had moderate to deep NLFs before treatment. Efficacy for NLF correction, as measured by change in wrinkle scores, was similar for both products throughout the 9-month study period. The volume of DGE injected to achieve optimal correction at the initial visit was significantly less than the volume of NASHA (mean [6 SD] volume of 0.88 [6 0.22] mL and 0.97 [6 0.29] mL, respectively; P \.0001). The majority (55%) of NLFs treated with DGE were injected with \1.0mL of product, compared to only 34% of NLFs treated with NASHA. In addition, the number of touch-ups (range, 0-2) required for optimal correction with DGE was significantly less than with NASHA (mean [6 SD] number of touch-ups of 0.76 [6 0.77] and 0.90 [6 0.79], respectively; P ¼.0052). Both dermal fillers were well tolerated, and adverse events were typically mild and transient. Conclusions: Significantly less volume of DGE was required to achieve optimal NLF correction compared to NASHA. More DGE-treated NLFs than NASHA-treated NLFs reached optimal correction with \1.0mL of product. Furthermore, fewer touch-ups were required with DGE than with NASHA. These data demonstrate the efficacy and utility of DGE for NLF correction. Commercial support: Sponsored by Mentor, Genzyme, and Johnson & Johnson.
J AM ACAD DERMATOL
AB143