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HIV facial lipoatrophy treatment with a volumizing hyaluronic acid filler
3168
3770
HIV facial lipoatrophy treatment with a volumizing hyaluronic acid filler Derek Ho, Sacramento VA Medical Center, Mather, CA, United States; Jared Jagdeo, MD, MS, Sacramento VA Medical Center, Mather, CA, United States Background: HIV facial lipoatrophy (HIV FLA) is a medical condition that occurs secondary to highly active anti-retroviral therapy (HAART), and affects quality-of-life and adherence to HAART medication regimen. There is an unmet need for treatment of HIV FLA due to limitations with FDA-approved fillers for this indication: poly-Llactic acid (Sculptra, Galderma) and calcium hydroxyapatite (Radiesse, Merz). Hyaluronic acid (HA) represents a different class of filler than the two HIV FLA FDAapproved classes with significant advantages for patients. A 20 mg/ml HA filler (Voluma, Allergan) may provide immediate aesthetic correction and fewer adverse effects compared to current FDA-approved treatments for HIV FLA. Another benefit of this filler includes the ability to use hyaluronidase to ‘‘correct’’ or ‘‘modify’’ HAtherapy.
The effect of needle size on pain perception in patients treated with botulinum toxin A injections: A split-face, patient- and injector-blinded randomized controlled trial Sanjana Iyengar, MD, Northwestern University, Chicago, IL, United States; Amelia Geisler, Northwestern University, Chicago, IL, United States; Divya Sadhwani, MD, Northwestern University, Chicago, IL, United States; Matthew Schaeffer, Northwestern University, Chicago, IL, United States; Kira Minkis, MD, PhD, Weill Cornell Medical College, New York, NY, United States; Murad Alam, MD, Northwestern University, Chicago, IL, United States
Methods: Subjects received one treatment (mid-face and temples) and one optional touch-up. All subjects have received their 3-month follow-up evaluation. Final study endpoints are at 12 months. Carruthers Lipoatrophy Severity Scale (CLSS) and Global Aesthetic Improvement Scale (GAIS) were used to evaluate efficacy. Subjects were scored pre-treatment, immediately posttreatment, and at all follow-up visits. CLSS is a 4-point scale (1 to 4): 1 as ‘‘mild and localized HIV FLA’’ and 4 as ‘‘HIV FLA extending up toward the eye sockets.’’ A Snellen chart was used to assess visual acuity immediately pre-, immediately post and 15 minutes posttreatment.
Background: Transcutaneous injection through smaller hollow bore needles may decrease patient discomfort, but current evidence is equivocal. Objective: This study compares injection discomfort with the use of 30- versus 32gauge needles. Method: In this double-blinded, split-face, randomized controlled trial, one side of the subject’s forehead received botulinum toxin in saline injected with a 32-gauge needle; other side, with a 30-gauge needle. In addition, each subject received randomized injections of saline to their upper inner arms. Subjects were between the ages of 25 to 70, in good health, female, and with moderate dynamic forehead/glabellar wrinkles. This study took place between November 2013 and February 2014 at an urban university dermatology clinic.
Results: Baseline HIV FLA severity was CLSS grade 2 (n ¼ 16; average 6.2cc HA received), grade 3 (n ¼ 3; average 9.3cc HA received), and grade 4 (n ¼ 1; 26cc HA received). Immediately post1st treatment, there was significant decrease for CLSS score (P \.001, Wilcoxon signed rank test) and 19/20 subjects achieved CLSS score of 1. At 3-month follow-up, there was significant decrease for CLSS score compared to baseline (P\.001) and all 20 subjects achieved CLSS score of 1. GAIS scored 100% (95% CI: 0.83, 1, binomial confidence interval) of subjects as ‘‘very much improved.’’ There were no treatment-related adverse events, vision or neurological changes. Conclusion: Midstudy results demonstrate excellent safety and efficacy and support use of this HA filler for treatment of HIV FLA. We hope future randomized controlled trials will demonstrate long-term safety and efficacy of this HA filler for treatment of HIV FLA with the desired ultimate goal of FDA-approval of this HA filler for treatment of HIV FLA.
Results: Twenty subjects completed the study. Primary outcomes measured patientreported pain on a visual analog scale (VAS) on either side of the face and arms, and the proportion of patients with clinically significant pain. Secondary outcomes included patient-reported characterization of the pain at both sites. Overall, facial and arm injections were nominally but not significantly more painful with 30-gauge needles (face: 4.16 vs 3.41, P ¼.33; arm: 1.66 vs 1.21, P ¼.45). For facial injections, 40% of subjects reported clinically significant pain (VAS $ 5.4) with the use of 30gauge needles versus 15% of subjects with the use of 32-gauge needles (OR: 3.80, CI: 1.05-13.78, P ¼.0424). Arm injections did not exhibit a difference in pain associated with needle type. There was no difference in character of pain associated with needle bore. Conclusion: For facial injections of neurotoxin in saline, 30-gauge needles were associated with a greater incidence of clinically significant pain than 32-gauge needles. For patients prone to experience clinically significant pain upon facial injections, use of 32-gauge needles may minimize this discomfort.
Allergan provided product support (hyaluronic acid filler) and stipend for study coordinator.
Commercial support: None identified.
2460
2733 Periorbital lipogranuloma after autologous fat injection for forehead augmentation Hyun Soo Lee, MD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea; Ji Young Yang, MD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea; You Chan Kim, MD, PhD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea Autologous fat injection (AFI) for facial augmentation has become a popular cosmetic procedure at local plastic surgery clinics. It is considered safe, with no severe adverse reactions compared to synthetic filler injection. However, we encountered the patient with periorbital lipogranuloma, a rare side effect of AFI for forehead augmentation. A 46-year-old woman presented with swelling on the left upper eyelid for 3 weeks. She had received cosmetic AFI on the forehead at local plastic surgery clinics twice, 7 and 4 months previously. The fat tissue was harvested from her thighs at the first injection and stored frozen for the second injection. Histopathologically, a foreign body reaction with lipid vacuoles, multinucleated giant cells, and fibrosis was observed at subcutaneous layer. The patient was diagnosed with lipogranuloma following AFI for forehead augmentation. Periorbital lipogranulomas after autologous fat injection for forehead augmentation have rarely been described in the literature of ophthalmology and plastic surgery in Korea. It is speculated that ice crystals formed inside the adipocytes during the process of cryopreservation, cause loss of viability, which may lead to a foreign body reaction and failure of engraftment. Dermatologists should know that periorbital lipogranuloma can rarely occur after AFI for forehead augmentation. Commercial support: None identified.
AB282
J AM ACAD DERMATOL
The facial adipose system: Its role in facial aging and approaches to volume restoration Neil Sadick, MD, Sadick Research Group, New York, NY, United States; Andrew Dorizas, MD, Sadick Research Group, New York, NY, United States; Nils Krueger, PhD, Rosenpark Research Wilhelminenstr, Germany; Amer Nassar, MD, Sadick Research Group, New York, NY, United States Background: Volume loss in facial adipose tissue plays a critical role in the aesthetics of facial aging. Furthermore, the facial adipose system is a complex network of distinct compartments, and a detailed understanding of these compartments is essential for optimal facial volume restoration. Objective: To review the facial adipose system, age-related changes, and the role of volume restoration products for facial rejuvenation. Methods: Publications including cadaver dissection studies and more recent studies using computed tomography were reviewed to provide an up-to-date understanding of the facial adipose system anatomy and age-related changes. Current volume restoration treatment options including hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid are discussed. Results: Facial aging is associated with volume loss in superficial and deep adipose compartments, including those of the forehead, cheek, lip, chin, and jowl areas. Volume restoration products can be used to address the age-related changes of the facial adipose compartments. Conclusion: Understanding the complex network of facial adipose compartments and their age-related changes allows for the optimal use of injectable volume restoration products for facial rejuvenation that can be customized to the anatomical needs of each patient. Neil S. Sadick, MD, has received research grants from Allergan, Inc. and Valeant Pharmaceuticals North America LLC, and is a member of the Advisory Board for Merz Pharmaceuticals and Valeant Pharmaceuticals North America LLC.
MAY 2016
3770
HIV facial lipoatrophy treatment with a volumizing hyaluronic acid filler Derek Ho, Sacramento VA Medical Center, Mather, CA, United States; Jared Jagdeo, MD, MS, Sacramento VA Medical Center, Mather, CA, United States Background: HIV facial lipoatrophy (HIV FLA) is a medical condition that occurs secondary to highly active anti-retroviral therapy (HAART), and affects quality-of-life and adherence to HAART medication regimen. There is an unmet need for treatment of HIV FLA due to limitations with FDA-approved fillers for this indication: poly-Llactic acid (Sculptra, Galderma) and calcium hydroxyapatite (Radiesse, Merz). Hyaluronic acid (HA) represents a different class of filler than the two HIV FLA FDAapproved classes with significant advantages for patients. A 20 mg/ml HA filler (Voluma, Allergan) may provide immediate aesthetic correction and fewer adverse effects compared to current FDA-approved treatments for HIV FLA. Another benefit of this filler includes the ability to use hyaluronidase to ‘‘correct’’ or ‘‘modify’’ HAtherapy.
The effect of needle size on pain perception in patients treated with botulinum toxin A injections: A split-face, patient- and injector-blinded randomized controlled trial Sanjana Iyengar, MD, Northwestern University, Chicago, IL, United States; Amelia Geisler, Northwestern University, Chicago, IL, United States; Divya Sadhwani, MD, Northwestern University, Chicago, IL, United States; Matthew Schaeffer, Northwestern University, Chicago, IL, United States; Kira Minkis, MD, PhD, Weill Cornell Medical College, New York, NY, United States; Murad Alam, MD, Northwestern University, Chicago, IL, United States
Methods: Subjects received one treatment (mid-face and temples) and one optional touch-up. All subjects have received their 3-month follow-up evaluation. Final study endpoints are at 12 months. Carruthers Lipoatrophy Severity Scale (CLSS) and Global Aesthetic Improvement Scale (GAIS) were used to evaluate efficacy. Subjects were scored pre-treatment, immediately posttreatment, and at all follow-up visits. CLSS is a 4-point scale (1 to 4): 1 as ‘‘mild and localized HIV FLA’’ and 4 as ‘‘HIV FLA extending up toward the eye sockets.’’ A Snellen chart was used to assess visual acuity immediately pre-, immediately post and 15 minutes posttreatment.
Background: Transcutaneous injection through smaller hollow bore needles may decrease patient discomfort, but current evidence is equivocal. Objective: This study compares injection discomfort with the use of 30- versus 32gauge needles. Method: In this double-blinded, split-face, randomized controlled trial, one side of the subject’s forehead received botulinum toxin in saline injected with a 32-gauge needle; other side, with a 30-gauge needle. In addition, each subject received randomized injections of saline to their upper inner arms. Subjects were between the ages of 25 to 70, in good health, female, and with moderate dynamic forehead/glabellar wrinkles. This study took place between November 2013 and February 2014 at an urban university dermatology clinic.
Results: Baseline HIV FLA severity was CLSS grade 2 (n ¼ 16; average 6.2cc HA received), grade 3 (n ¼ 3; average 9.3cc HA received), and grade 4 (n ¼ 1; 26cc HA received). Immediately post1st treatment, there was significant decrease for CLSS score (P \.001, Wilcoxon signed rank test) and 19/20 subjects achieved CLSS score of 1. At 3-month follow-up, there was significant decrease for CLSS score compared to baseline (P\.001) and all 20 subjects achieved CLSS score of 1. GAIS scored 100% (95% CI: 0.83, 1, binomial confidence interval) of subjects as ‘‘very much improved.’’ There were no treatment-related adverse events, vision or neurological changes. Conclusion: Midstudy results demonstrate excellent safety and efficacy and support use of this HA filler for treatment of HIV FLA. We hope future randomized controlled trials will demonstrate long-term safety and efficacy of this HA filler for treatment of HIV FLA with the desired ultimate goal of FDA-approval of this HA filler for treatment of HIV FLA.
Results: Twenty subjects completed the study. Primary outcomes measured patientreported pain on a visual analog scale (VAS) on either side of the face and arms, and the proportion of patients with clinically significant pain. Secondary outcomes included patient-reported characterization of the pain at both sites. Overall, facial and arm injections were nominally but not significantly more painful with 30-gauge needles (face: 4.16 vs 3.41, P ¼.33; arm: 1.66 vs 1.21, P ¼.45). For facial injections, 40% of subjects reported clinically significant pain (VAS $ 5.4) with the use of 30gauge needles versus 15% of subjects with the use of 32-gauge needles (OR: 3.80, CI: 1.05-13.78, P ¼.0424). Arm injections did not exhibit a difference in pain associated with needle type. There was no difference in character of pain associated with needle bore. Conclusion: For facial injections of neurotoxin in saline, 30-gauge needles were associated with a greater incidence of clinically significant pain than 32-gauge needles. For patients prone to experience clinically significant pain upon facial injections, use of 32-gauge needles may minimize this discomfort.
Allergan provided product support (hyaluronic acid filler) and stipend for study coordinator.
Commercial support: None identified.
2460
2733 Periorbital lipogranuloma after autologous fat injection for forehead augmentation Hyun Soo Lee, MD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea; Ji Young Yang, MD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea; You Chan Kim, MD, PhD, Department of Dermatology, Ajou University School of Medicine, Suwon, South Korea Autologous fat injection (AFI) for facial augmentation has become a popular cosmetic procedure at local plastic surgery clinics. It is considered safe, with no severe adverse reactions compared to synthetic filler injection. However, we encountered the patient with periorbital lipogranuloma, a rare side effect of AFI for forehead augmentation. A 46-year-old woman presented with swelling on the left upper eyelid for 3 weeks. She had received cosmetic AFI on the forehead at local plastic surgery clinics twice, 7 and 4 months previously. The fat tissue was harvested from her thighs at the first injection and stored frozen for the second injection. Histopathologically, a foreign body reaction with lipid vacuoles, multinucleated giant cells, and fibrosis was observed at subcutaneous layer. The patient was diagnosed with lipogranuloma following AFI for forehead augmentation. Periorbital lipogranulomas after autologous fat injection for forehead augmentation have rarely been described in the literature of ophthalmology and plastic surgery in Korea. It is speculated that ice crystals formed inside the adipocytes during the process of cryopreservation, cause loss of viability, which may lead to a foreign body reaction and failure of engraftment. Dermatologists should know that periorbital lipogranuloma can rarely occur after AFI for forehead augmentation. Commercial support: None identified.
AB282
J AM ACAD DERMATOL
The facial adipose system: Its role in facial aging and approaches to volume restoration Neil Sadick, MD, Sadick Research Group, New York, NY, United States; Andrew Dorizas, MD, Sadick Research Group, New York, NY, United States; Nils Krueger, PhD, Rosenpark Research Wilhelminenstr, Germany; Amer Nassar, MD, Sadick Research Group, New York, NY, United States Background: Volume loss in facial adipose tissue plays a critical role in the aesthetics of facial aging. Furthermore, the facial adipose system is a complex network of distinct compartments, and a detailed understanding of these compartments is essential for optimal facial volume restoration. Objective: To review the facial adipose system, age-related changes, and the role of volume restoration products for facial rejuvenation. Methods: Publications including cadaver dissection studies and more recent studies using computed tomography were reviewed to provide an up-to-date understanding of the facial adipose system anatomy and age-related changes. Current volume restoration treatment options including hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid are discussed. Results: Facial aging is associated with volume loss in superficial and deep adipose compartments, including those of the forehead, cheek, lip, chin, and jowl areas. Volume restoration products can be used to address the age-related changes of the facial adipose compartments. Conclusion: Understanding the complex network of facial adipose compartments and their age-related changes allows for the optimal use of injectable volume restoration products for facial rejuvenation that can be customized to the anatomical needs of each patient. Neil S. Sadick, MD, has received research grants from Allergan, Inc. and Valeant Pharmaceuticals North America LLC, and is a member of the Advisory Board for Merz Pharmaceuticals and Valeant Pharmaceuticals North America LLC.
MAY 2016