Juvéderm injectable gel: a multicenter, double-blind, randomized study of safety and effectiveness
| Autor: | Mark A, Pinsky, Jane A, Thomas, Diane K, Murphy, Patricia S, Walker, Shilesh, Iyer |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male medicine.medical_specialty Injections Subcutaneous Biocompatible Materials Cosmetic Techniques Nose Dermal Fillers law.invention Double blind Randomized controlled trial Clinical Protocols Double-Blind Method law Juvéderm medicine Humans Prospective Studies Hyaluronic Acid Prospective cohort study Wrinkle Aged business.industry General Medicine Middle Aged Nasolabial fold Lip Surgery Skin Aging medicine.anatomical_structure Treatment Outcome Multicenter study Research Design Female Collagen medicine.symptom business Follow-Up Studies |
| Zdroj: | Aesthetic surgery journal. 28(1) |
| ISSN: | 1527-330X |
| Popis: | Background A high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation is the hallmark of the new Juvederm dermal fillers. Objective To determine the long-term effectiveness and safety of Juvederm Ultra and Ultra Plus injectable gel. Methods In the multicenter study approved by the Food and Drug Administration, subjects were randomized to treatment with Juvederm Ultra or Ultra Plus in one nasolabial fold (NLF) and Zyplast collagen in the other. After optimal correction was achieved (treatment plus up to 2 touch-ups at 2-week intervals), effectiveness was assessed on a 5-point scale through the 6-month study period. An additional poststudy visit provided long-term effectiveness data. Safety was evaluated through subjects' daily diaries for 14 days after treatment. Results A total of 292 subjects were randomized and treated, 146 in each cohort. A total of 280 subjects completed the 6-month study, and 227 attended the poststudy visit. Clinically significant mean wrinkle correction (≥ 1 point improvement) was still in evidence at >9 months for both Juvederm formulations but not for the Zyplast control. At >9 months, 75% of Juvederm Ultra– and 81% of Juvederm Ultra Plus–treated NLFs maintained a clinically significant correction. Moreover, 78% of NLFs treated with Juvederm Ultra Plus still had a clinically significant improvement beyond 1 year. Local treatment site reactions were comparable for Juvederm and Zyplast. Conclusions These next-generation HA dermal fillers can be reliably expected to provide long-term correction, with Juvederm Ultra lasting more than 9 months and Juvederm Ultra Plus lasting for a year or more. |
| Databáze: | OpenAIRE |
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