利益冲突声明

您有否接受任何资金来支持研究这个主题？
是
请注明名称（个人，公司，学会等等）: QuantifiCare

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作的完成感谢以下机构的支持： QuantifiCare

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。 Aptos

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。

Objectives: Hyaluronidase, an enzyme naturally present in skin, catalyzes depolymerization of hyaluronic acid (HA) via hydrolysis of its glycosidic bonds. Hyaluronidase-mediated degradation of HA also increases permeability of the skin and connective tissue, and has the direct effect of reducing volume related to the presence of hyaluronic acid.

The objective of this evaluation was to assess safety, efficacy and tolerability of a new topical cosmetic formulation of hyaluronidase enzymatically complexed with essential oils, in patients with chronic contour irregularities following HA filler treatments.

Introduction: Injectable hyaluronidase is used off-label for correction of skin contour irregularities, nodules or ischemia following HA fillers, and sometimes for non-HA nodules with the aim of facilitating nodule dispersion. Some hyaluronidase formulations have been associated with local allergic reactions (incidence 0.05-0.69% rising to 31.3% with 200,000 IU), and rare urticaria and angioedema (incidence < 0.1%).

Availability and use of injectable hyaluronidase are limited by country-specific regulations. Some patients are unwilling to undergo further injections to address filler complications.

Materials / method: Intro (contd.): There are no evidence-based methodologies to determine accurately the appropriate hyaluronidase dosage to address nodular complications while avoiding HA degradation to the extent that desirable tissue augmentation is diminished or lost.

After ethical board approval, 17 females aged 23 to 54 (six having skin phototypes IV-VI) with chronic post-filler contour irregularities received 1 to 3 sessions of topical application with the new formulation. Treated areas were infraorbital (10), lips (5) and malar festoons (2). Post-application massage was performed in office and at home.

Results: Two to four weeks after the final session, physician-assessed contour improvement was 8-10/10 for seven patients, 5-7/10 for six, 1-4/10 for three, and 0/10 for one patient. Fifteen patients evaluated their skin as more uniform (5/10 to 10/10). Satisfaction scores were 7-10/10 for thirteen patients, 6/10 for two, and 0-1/10 for two. All evaluated their care as comfortable to extremely comfortable.

Conclusion: Based on this pilot evaluation, the topical cosmetic formulation of hyaluronidase with essential oils was safe, efficacious and well-tolerated. It may be of value in countries where the use of injectable hyaluronidase is limited, and for patients in whom injectable hyaluronidase is contraindicated or declined.. Larger, controlled studies will raise the evidence level for the use of this novel formulation to adjust undesirable outcomes from HA injections and facilitate optimal results.

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作的完成感谢以下机构的支持： SOFTFIL

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。

利益冲突声明

您有否接受任何资金来支持研究这个主题？
是
请注明名称（个人，公司，学会等等）: Pulse Biosciences

您是否接受过关于这项研究的任何酬金或其他报酬？
是
请注明名称（个人，公司，学会等等）: Pulse Biosciences

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
是
请注明名称（个人，公司，学会等等）: Establishment Labs

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作的完成感谢以下机构的支持： Establishment Labs

Objectives: Present the features of the new dermal filler range as well as its first clinical uses.

Introduction: The company has developed an innovative hyaluronic acid (HA) technology based on a new cross-linking process allowing the optimal combination of essential characteristics known in the development of dermal fillers. As a result, the new dermal fillers are adapted to the tissue and anatomical specificities of each facial rejuvenation indication. The devices are adequate to maintain naturalness of facial expressions and improve the quality of life of persons affected by structural and physiological alterations of the face.

Materials / method: The new HA dermal fillers present various characteristics so as to better correspond to the intended uses. According to the manufacturer, the ideal HA filler should be long lasting, without side effects and easy to inject. A first medical study was performed to validate the new dermal filler range. It was carried out on 30 patients presenting HIV treatment-related facial lipoatrophy, with two devices from the new range: one product* was injected in depth to fill severe wrinkles and folds while another product* was utilised to correct superficial volume loss.

Results: Based on the new technology, both products showed very good efficacy in the treatment of midface volume loss. Investigators and patients observed an improvement of facial appearance from 14 days after the initial treatment to 12 months. The score of facial lipoatrophy also decreased significantly. Furthermore, the patients’ quality of life was improved significantly after injections and stayed stable over time. Treatment is considered as safe as all adverse effects observed were usual, transient and expected.

Conclusion: The HA dermal fillers range based on this new technology has proven its safety and effectiveness on patients affected by HIV treatment induced facial lipoatrophy. Two fillers are used in combination in deep and superficial injection, to provide a full correction of midface volume loss for an optimal result and improvement of quality of life. These results are very promising in facial rejuvenation for all products. Therefore, clinical studies in aesthetic indications have been launched.

*Device technical file under review by the Notified Body for CE certification

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
否

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作没有任何直接或间接的资金支持。由作者自己承担责任。