A Randomized, Evaluator-Blind, Multicenter Comparison of the Efficacy and Tolerability of Perlane versus Zyplast in the Correction of Nasolabial Folds

医学 皱纹 耐受性 鼻唇沟 透明质酸 美容技术 外科 随机对照试验 可视模拟标度 不利影响 内科学 老年学 解剖
作者
Christer Lindqvist,Stein Tveten,Bjørn Eriksen Bondevik,Dan Fagrell
出处
期刊:Plastic and Reconstructive Surgery [Lippincott Williams & Wilkins]
卷期号:115 (1): 282-289 被引量:108
标识
DOI:10.1097/01.prs.0000146704.02347.36
摘要

Bovine collagen is widely used as a dermal filler for facial soft-tissue augmentation, but it provides only temporary cosmetic improvement. Nonanimal stabilized hyaluronic acid has reduced potential for immunogenicity and hypersensitivity and may provide a more durable aesthetic result. Sixty-eight patients with prominent nasolabial folds were randomized to intradermal treatment with nonanimal stabilized hyaluronic acid gel (Perlane) and bovine collagen (Zyplast) on contralateral sides of the face. On achievement of "optimal cosmetic result" (baseline), patients were followed up for 6 months; bilateral retreatment with Perlane was offered at 6 or 9 months after baseline. Responses were evaluated at 2, 4, 6, 9, and 12 months after baseline. Investigator-based and patient-based ratings indicated that Perlane was more effective than Zyplast in maintaining cosmetic correction. According to investigator-based Wrinkle Severity Rating Scale assessments at 6 and 9 months after baseline, Perlane was superior in 50.0 percent and 48.8 percent of patients, respectively, whereas Zyplast was superior in 10.3 percent and 14.0 percent of patients, respectively (p < 0.0004). Investigator-based Global Aesthetic Improvement Scale assessment at 9 months after baseline indicated that Perlane was superior in 48.8 percent of patients, whereas Zyplast was superior in 14.0 percent of patients (p = 0.0025). "Optimal cosmetic result" was achieved with a smaller volume of Perlane than Zyplast (mean, 1.2 ml versus 2.1 ml). Local injection-site reactions (redness, swelling, pruritus, and induration) were less frequent with Perlane than with Zyplast. Delayed-onset reactions were rare and did not reoccur after Perlane retreatment. Perlane has acceptable long-term safety and offers a longer-lasting aesthetic improvement than Zyplast.
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