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The efficacy, safety, and subject satisfaction of pain management of a self-occlusive topical anesthetic cream during and after filler injections for the correction of nasolabial folds
P7573
P8190
Subject-reported outcomes over 2 years with a volumizing hyaluronic acid filler for midface volume deficit Sue Ellen Cox, MD, University of North Carolina and Aesthetic Solutions, Chapel Hill, NC, United States; Deepali Paradkar, PhD, Allergan, Inc, Irvine, CA, United States; Diane Murphy, MBA, Allergan, Inc, Irvine, CA, United States; Julius Few, MD, University of Chicago, Chicago, IL, United States
Methods: Fifteen North American investigational sites used a volumizing HA filler to treat 235 subjects who had moderate to severe age-related midface volume deficit. At quarterly follow-up visits for 2 years the subjects rated the treatment outcomes on the Global Aesthetic Improvement Scale, overall satisfaction with facial appearance, satisfaction with midfacial regions, look and feel of the midface, achievement of treatment goal, and self-perception of age. Subjects also completed 30-day diaries to record common treatment site responses. Results: At 6 months after treatment, 93% of subjects rated their cheek volume as improved or much improved on the Global Aesthetic Improvement Scale, and a majority of subjects still felt that way at 2 years. Improvement in satisfaction with facial appearance over baseline was noted by 90% of subjects at 6 months and 76% of subjects at 2 years. Satisfaction with the outer and lower cheek areas improved from 23% at baseline to 86% at 6 months, and cheek bone projection improved from 30% to 85%. At baseline, a majority of subjects rated their cheeks as making them look tired, sad, unattractive, and older than they wanted to look. Statistically significant improvements were noted for all of these categories at 6 months. Two-thirds of subjects rated their treatment goals as having been met at 6 months, and almost half agreed that the goals were still attained at 2 years. At every timepoint through 2 years, a majority of subjects perceived themselves as looking younger than they did at baseline. On average, subjects reported looking 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses reported were tenderness, swelling, firmness, and lumps/bumps, most of which were mild to moderate in severity and lasted 2 weeks or less.
The efficacy, safety, and subject satisfaction of pain management of a selfocclusive topical anesthetic cream during and after filler injections for the correction of nasolabial folds Kenneth R Beer, MD, PA, General, Cosmetic, and Surgical Dermatology, West Palm Beach, FL, United States; Mary Lupo, MD, Lupo Center for Aesthetic and General Dermatology, New Orleans, LA, United States In an effort to provide more efficacious topical anesthesia, some physicians have used compounded topical anesthetics that lack standardization to make patients more comfortable during and after filler injections. Efficacy, safety, and subject satisfaction were assessed in this multicenter, open-label, randomized, split-face study. An FDA approved anesthetic cream of lidocaine and tetracaine 7%/7% (LT cream) was compared to a compounded topical anesthetic (BLT ointment: benzocaine 20%, lidocaine 6%, and tetracaine 4%) during and after hyaluronic acid filler injections for the correction of nasolabial folds (NLF). This study included 51 subjects who received concurrent 30-minute applications of LT cream and BLT ointment to opposite sides of the subjects face before injection. This study group comprised primarily women (98%) who were white (98%) with Fitzpatrick skin types III to IV (84%) and a median age of 49 years. There were no significant differences in subject-reported visual analog scale (VAS) scores or investigator assessment of subject pain at any time point. However, a significant difference was reported by independent observers who believed that most subjects experienced less pain with LT cream than with BLT ointment at the first needle stick (P ¼.045), but not at any other time point. Most subjects reported that the level of pain experienced at the first needle stick was minimal or mild for the LT cream and BLT ointment groups (74% vs 76%, respectively). Likewise, most investigators (86% for both treatments) reported adequate anesthesia with both topical anesthetics. There was a significant difference in the distribution of erythema severity and edema severity between the LT cream and BLT ointment groups (P ¼ .003). During the study, 3 subjects reported treatment emergent AEs (implant site bruising) that were mild in severity and definitely unrelated to the topical anesthetics. LT cream is an effective and safe alternative to use with filler injections for the correction of nasolabial folds.
Conclusion: The volumizing HA filler for age-related midface volume deficit is effective and well-tolerated from the subject perspective, with results lasting up to 2 years.
Study funded and poster/editorial support provided by Galderma Laboratories, L.P.
Objective: To examine the effectiveness of a volumizing hyaluronic acid (HA) filler (Allergan, Inc) from the subject perspective.
Supported by Allergan, Inc.
P8317
P8523
Background: One of the desired outcomes in dermatologic surgeries and other invasive procedures is to have the resulting scar be as aesthetically pleasing as possible. Although a scar can be viewed as unsightly, the primary purpose of a scar is to reduce the likelihood of infection of the damaged area. There are many commercially available methods for reducing the appearance of scars. One of the most common ingredients in these treatments is onion extract (Allium cepa). Studies have established antiinflammatory properties of onion extracts and other onion-based compounds, the 2 ingredients in onion extract being cepanes and thiosulfinates. Patients may prefer these onion extractebased products because of their ‘‘botanical’’ ingredients, ample availability, and low cost compared to other scar reducing products. Objective: To present data from a randomized, controlled, 8 week study of a new onion extract gel test product referred to as PM onion extract gel in reducing the appearance of scars. Methods: At baseline, 44 males and/or female participants were evaluated and enrolled into the study. PM onion extract gel was applied once daily in the evenings. Each participant was required to have 2 scars in the same evaluation area (different scar types were admitted). The wounds were documented by high resolution scientifically matched photography and evaluated by an expert grader at baseline and at weeks 2, 4, and 8. Participants were also required to complete a subjective questionnaire at the mentioned time points. Results: The investigator assessments showed that the PM onion extract gel significantly improved the appearance of scars over an 8-week period. The majority of the responses to the subject questionnaire were consistent with the conclusion reached by the expert visual grader and the photogrammetry, in that scars were less visible than before they started treatment. Conclusions: The new proprietary PM onion extract gel significantly improves the appearance of various types of scars after 8 weeks of once-daily evening application.
Twice daily application of a topical formulation containing caffeine, forskolin, and the TPM delivery system was able to significantly reduce the visible appearance of cellulite Paul Gavin, PhD, Phosphagenics Ltd, Clayton, Australia; Biljana Nikolovski, PhD, Phosphagenics Ltd, Clayton, Australia; Giacinto Gaetano, Phosphagenics Ltd, Clayton, Australia; Mahmoud El-Tamimy, PhD, Phosphagenics Ltd, Clayton, Australia; Roksan Libinaki, PhD, Phosphagenics Ltd, Clayton, Australia Research and development has shown that a mixture of tocopheryl phosphate (TP) and di tocopheryl phosphate (T2P) was able increase the absorption of molecules into or through the skin after topical application. This mixture has formed the basis of a novel delivery technology called TPM. TPM was formulated with the lypolytic actives, caffeine and forskolin, to develop a topical formulation able to reduce the visible appearance of cellulite. Thirty women with visible cellulite on both thighs were recruited for the study. The test product was applied twice per day (morning and night) to the affected area of a single thigh over a 56-day period. The opposite thigh was left as an untreated control. Elasticity and viscoelastic properties of the skin were measured as a function of flexibility and firmness using a cutometer. Hydration level of the skin surface was evaluated instrumentally using a Corneometer. The efficacy and tolerance were evaluated using panelist selfassessment via questionnaire responses and measurements of upper thigh circumferences were also collected. A subset of 5 subjects were randomly chosen for additional photogrammetric investigation, where image analysis software was used to quantify changes in cellulite condition observed in the scientifically matched photographs. Analysis of the chosen parameters was conducted before the initial application (at baseline) and again after 14, 28, 42, and 56 days of use. Cutometer readings demonstrated that the test material increased the average the skin elasticity by 10.36% and hydration by 52.63% after 56 days of treatment when compared to the untreated leg, Both increases were statistically significant. Image analysis software demonstrated that the test product progressively reduced the visual appearance of the cellulite. At the end of the study, the test product significantly reduced the visible appearance of cellulate by an average of 57.40% with maximum of 72.12%. The test product also significantly reduced the average thigh circumference by an average of 0.92% (0.36 cm) after 8 weeks of use. Subjective questionnaire responses corroborated instrumental data. The majority of test panelists responded positively to perceived benefits with the test product demonstrating improvement in skin’s firmness, tightness, and reduction in skin’s looseness and bagginess after 56 days of use. At the study completion, a majority of test panelists perceived the test material to be an effective anticellulite product.
Supported by Merz Pharmaceuticals, LLC.
Supported by Phosphagenics Ltd.
The ability of a new proprietary onion extract gel to reduce the appearance of scars: A randomized, controlled study Stefan Plaum, MD, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Alan Fleischer, MD, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Amit Verma, PhD, MPH, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Babajide Olayinka, MS, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, LLC, Greensboro, NC, United States
MAY 2014
J AM ACAD DERMATOL
AB21
P8190
Subject-reported outcomes over 2 years with a volumizing hyaluronic acid filler for midface volume deficit Sue Ellen Cox, MD, University of North Carolina and Aesthetic Solutions, Chapel Hill, NC, United States; Deepali Paradkar, PhD, Allergan, Inc, Irvine, CA, United States; Diane Murphy, MBA, Allergan, Inc, Irvine, CA, United States; Julius Few, MD, University of Chicago, Chicago, IL, United States
Methods: Fifteen North American investigational sites used a volumizing HA filler to treat 235 subjects who had moderate to severe age-related midface volume deficit. At quarterly follow-up visits for 2 years the subjects rated the treatment outcomes on the Global Aesthetic Improvement Scale, overall satisfaction with facial appearance, satisfaction with midfacial regions, look and feel of the midface, achievement of treatment goal, and self-perception of age. Subjects also completed 30-day diaries to record common treatment site responses. Results: At 6 months after treatment, 93% of subjects rated their cheek volume as improved or much improved on the Global Aesthetic Improvement Scale, and a majority of subjects still felt that way at 2 years. Improvement in satisfaction with facial appearance over baseline was noted by 90% of subjects at 6 months and 76% of subjects at 2 years. Satisfaction with the outer and lower cheek areas improved from 23% at baseline to 86% at 6 months, and cheek bone projection improved from 30% to 85%. At baseline, a majority of subjects rated their cheeks as making them look tired, sad, unattractive, and older than they wanted to look. Statistically significant improvements were noted for all of these categories at 6 months. Two-thirds of subjects rated their treatment goals as having been met at 6 months, and almost half agreed that the goals were still attained at 2 years. At every timepoint through 2 years, a majority of subjects perceived themselves as looking younger than they did at baseline. On average, subjects reported looking 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses reported were tenderness, swelling, firmness, and lumps/bumps, most of which were mild to moderate in severity and lasted 2 weeks or less.
The efficacy, safety, and subject satisfaction of pain management of a selfocclusive topical anesthetic cream during and after filler injections for the correction of nasolabial folds Kenneth R Beer, MD, PA, General, Cosmetic, and Surgical Dermatology, West Palm Beach, FL, United States; Mary Lupo, MD, Lupo Center for Aesthetic and General Dermatology, New Orleans, LA, United States In an effort to provide more efficacious topical anesthesia, some physicians have used compounded topical anesthetics that lack standardization to make patients more comfortable during and after filler injections. Efficacy, safety, and subject satisfaction were assessed in this multicenter, open-label, randomized, split-face study. An FDA approved anesthetic cream of lidocaine and tetracaine 7%/7% (LT cream) was compared to a compounded topical anesthetic (BLT ointment: benzocaine 20%, lidocaine 6%, and tetracaine 4%) during and after hyaluronic acid filler injections for the correction of nasolabial folds (NLF). This study included 51 subjects who received concurrent 30-minute applications of LT cream and BLT ointment to opposite sides of the subjects face before injection. This study group comprised primarily women (98%) who were white (98%) with Fitzpatrick skin types III to IV (84%) and a median age of 49 years. There were no significant differences in subject-reported visual analog scale (VAS) scores or investigator assessment of subject pain at any time point. However, a significant difference was reported by independent observers who believed that most subjects experienced less pain with LT cream than with BLT ointment at the first needle stick (P ¼.045), but not at any other time point. Most subjects reported that the level of pain experienced at the first needle stick was minimal or mild for the LT cream and BLT ointment groups (74% vs 76%, respectively). Likewise, most investigators (86% for both treatments) reported adequate anesthesia with both topical anesthetics. There was a significant difference in the distribution of erythema severity and edema severity between the LT cream and BLT ointment groups (P ¼ .003). During the study, 3 subjects reported treatment emergent AEs (implant site bruising) that were mild in severity and definitely unrelated to the topical anesthetics. LT cream is an effective and safe alternative to use with filler injections for the correction of nasolabial folds.
Conclusion: The volumizing HA filler for age-related midface volume deficit is effective and well-tolerated from the subject perspective, with results lasting up to 2 years.
Study funded and poster/editorial support provided by Galderma Laboratories, L.P.
Objective: To examine the effectiveness of a volumizing hyaluronic acid (HA) filler (Allergan, Inc) from the subject perspective.
Supported by Allergan, Inc.
P8317
P8523
Background: One of the desired outcomes in dermatologic surgeries and other invasive procedures is to have the resulting scar be as aesthetically pleasing as possible. Although a scar can be viewed as unsightly, the primary purpose of a scar is to reduce the likelihood of infection of the damaged area. There are many commercially available methods for reducing the appearance of scars. One of the most common ingredients in these treatments is onion extract (Allium cepa). Studies have established antiinflammatory properties of onion extracts and other onion-based compounds, the 2 ingredients in onion extract being cepanes and thiosulfinates. Patients may prefer these onion extractebased products because of their ‘‘botanical’’ ingredients, ample availability, and low cost compared to other scar reducing products. Objective: To present data from a randomized, controlled, 8 week study of a new onion extract gel test product referred to as PM onion extract gel in reducing the appearance of scars. Methods: At baseline, 44 males and/or female participants were evaluated and enrolled into the study. PM onion extract gel was applied once daily in the evenings. Each participant was required to have 2 scars in the same evaluation area (different scar types were admitted). The wounds were documented by high resolution scientifically matched photography and evaluated by an expert grader at baseline and at weeks 2, 4, and 8. Participants were also required to complete a subjective questionnaire at the mentioned time points. Results: The investigator assessments showed that the PM onion extract gel significantly improved the appearance of scars over an 8-week period. The majority of the responses to the subject questionnaire were consistent with the conclusion reached by the expert visual grader and the photogrammetry, in that scars were less visible than before they started treatment. Conclusions: The new proprietary PM onion extract gel significantly improves the appearance of various types of scars after 8 weeks of once-daily evening application.
Twice daily application of a topical formulation containing caffeine, forskolin, and the TPM delivery system was able to significantly reduce the visible appearance of cellulite Paul Gavin, PhD, Phosphagenics Ltd, Clayton, Australia; Biljana Nikolovski, PhD, Phosphagenics Ltd, Clayton, Australia; Giacinto Gaetano, Phosphagenics Ltd, Clayton, Australia; Mahmoud El-Tamimy, PhD, Phosphagenics Ltd, Clayton, Australia; Roksan Libinaki, PhD, Phosphagenics Ltd, Clayton, Australia Research and development has shown that a mixture of tocopheryl phosphate (TP) and di tocopheryl phosphate (T2P) was able increase the absorption of molecules into or through the skin after topical application. This mixture has formed the basis of a novel delivery technology called TPM. TPM was formulated with the lypolytic actives, caffeine and forskolin, to develop a topical formulation able to reduce the visible appearance of cellulite. Thirty women with visible cellulite on both thighs were recruited for the study. The test product was applied twice per day (morning and night) to the affected area of a single thigh over a 56-day period. The opposite thigh was left as an untreated control. Elasticity and viscoelastic properties of the skin were measured as a function of flexibility and firmness using a cutometer. Hydration level of the skin surface was evaluated instrumentally using a Corneometer. The efficacy and tolerance were evaluated using panelist selfassessment via questionnaire responses and measurements of upper thigh circumferences were also collected. A subset of 5 subjects were randomly chosen for additional photogrammetric investigation, where image analysis software was used to quantify changes in cellulite condition observed in the scientifically matched photographs. Analysis of the chosen parameters was conducted before the initial application (at baseline) and again after 14, 28, 42, and 56 days of use. Cutometer readings demonstrated that the test material increased the average the skin elasticity by 10.36% and hydration by 52.63% after 56 days of treatment when compared to the untreated leg, Both increases were statistically significant. Image analysis software demonstrated that the test product progressively reduced the visual appearance of the cellulite. At the end of the study, the test product significantly reduced the visible appearance of cellulate by an average of 57.40% with maximum of 72.12%. The test product also significantly reduced the average thigh circumference by an average of 0.92% (0.36 cm) after 8 weeks of use. Subjective questionnaire responses corroborated instrumental data. The majority of test panelists responded positively to perceived benefits with the test product demonstrating improvement in skin’s firmness, tightness, and reduction in skin’s looseness and bagginess after 56 days of use. At the study completion, a majority of test panelists perceived the test material to be an effective anticellulite product.
Supported by Merz Pharmaceuticals, LLC.
Supported by Phosphagenics Ltd.
The ability of a new proprietary onion extract gel to reduce the appearance of scars: A randomized, controlled study Stefan Plaum, MD, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Alan Fleischer, MD, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Amit Verma, PhD, MPH, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Babajide Olayinka, MS, Merz Pharmaceuticals, LLC, Greensboro, NC, United States; Bhushan Hardas, MD, MBA, Merz Pharmaceuticals, LLC, Greensboro, NC, United States
MAY 2014
J AM ACAD DERMATOL
AB21