一项多中心研究评估了用于治疗 Fitzpatrick 皮肤类型 IV、V 和 VI 的受试者鼻唇沟的具有粘性聚缩多聚糖基质的透明质酸的安全性和有效性。
A multicenter study of the safety and effectiveness of hyaluronic acid with a cohesive polydensified matrix for treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI.
机构信息
Montclair, N.J.; Los Angeles, Calif.; Washington, D.C.; and Glenn Dale, Md. From private practice; the Vitiligo and Pigmentation Institute of Southern California; the Department Dermatology, University of California, Los Angeles; Howard University School of Medicine; and the Callender Skin and Laser Center.
出版信息
Plast Reconstr Surg. 2013 Oct;132(4 Suppl 2):41S-47S. doi: 10.1097/PRS.0b013e318299ff53.
BACKGROUND
Although the use of the hyaluronic acid with cohesive polydensified matrix hyaluronic acid has been well explored in subjects with lighter skin (i.e., Fitzpatrick skin types I, II, and III), further exploration in subjects with Fitzpatrick skin types IV, V, and IV is warranted. The primary purpose of the study was to assess the safety of a cohesive polydensified matrix hyaluronic acid in the correction of nasolabial folds in subjects with Fitzpatrick skin types IV, V and VI, especially assessment of hyperpigmentation, hypopigmentation, and scarring. Effectiveness was also assessed.
METHODS
A total of 93 subjects were enrolled in this 24-week investigation at three sites in the United States. All were injected bilaterally for nasolabial fold correction with cohesive polydensified matrix hyaluronic acid. Assessments included the recording of adverse events; injected volumes; wrinkle severity ratings; and global aesthetic improvement by evaluating investigators, treating investigators, and study subjects.
RESULTS
Injection of cohesive polydensified matrix hyaluronic acid for the treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI showed no evidence of an association with hypopigmentation, hyperpigmentation, or scarring. Adverse events reported were typical of dermal filler injections with respect to type, rate, duration, and severity.
CONCLUSION
Cohesive polydensified matrix hyaluronic acid is a safe and well-tolerated dermal filler for subjects with Fitzpatrick skin types IV, V, and VI.
背景
尽管含有粘性聚交联透明质酸的透明质酸已在肤色较浅的受试者（即 Fitzpatrick 皮肤类型 I、II 和 III）中得到了充分的研究，但仍需要在 Fitzpatrick 皮肤类型 IV、V 和 VI 的受试者中进一步探索。该研究的主要目的是评估粘性聚交联透明质酸在纠正 Fitzpatrick 皮肤类型 IV、V 和 VI 受试者鼻唇沟皱纹中的安全性，特别是评估色素沉着过度、色素减退和瘢痕形成。还评估了疗效。
方法
共有 93 名受试者在美国的三个地点参加了这项为期 24 周的研究。所有受试者均双侧注射粘性聚交联透明质酸进行鼻唇沟皱纹矫正。评估包括记录不良事件；注射量；皱纹严重程度评分；以及通过评估员、治疗员和研究对象评估的整体美学改善。
结果
在 Fitzpatrick 皮肤类型 IV、V 和 VI 的受试者中，注射粘性聚交联透明质酸治疗鼻唇沟皱纹，未发现与色素减退、色素沉着过度或瘢痕形成有关。报告的不良事件在类型、发生率、持续时间和严重程度方面与真皮填充剂注射典型相关。
结论
粘性聚交联透明质酸是一种安全且耐受性良好的真皮填充剂，适用于 Fitzpatrick 皮肤类型 IV、V 和 VI 的受试者。
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