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一种新型局部制剂对面部皱纹减少和皮肤再生的前瞻性随机临床试验。

Prospective randomized clinical study of a new topical formulation for face wrinkle reduction and dermal regeneration.

机构信息

Aesthetic Medicine Department, Cosmetic Surgeon at Univeristy Tor Vergata of Roma, Rome, Italy.

Aesthetic Doctor, Private Practice in Rome, Rome, Italy.

出版信息

J Cosmet Dermatol. 2021 Sep;20(9):2832-2840. doi: 10.1111/jocd.13937. Epub 2021 Jan 16.

DOI:10.1111/jocd.13937
PMID:33453095
Abstract

BACKGROUND

A new topical formulation (TF) based on 3 main lifting components has been developed to reduce superficial facial wrinkles.

OBJECTIVES

Determine the effectiveness of this new TF in reducing superficial face wrinkles and restructuring the dermal matrix.

METHODS

Women, aged 30-65 y.o. with moderate to severe crow's feet wrinkles were included.

EXCLUSION CRITERIA

men; younger than 30 or older than 65 years old; smokers. Patients received 15 IU of botulinum toxin on crow's feet and 2 creams. Fifty patients (Group 1) applied the TP (Product A) and 50 (Group 2) a placebo (Product B). Assessments were made by digital macro-photography's, Antera 3D, and a patient satisfaction questionnaire.

RESULTS

From April to June 2019, 100 women were enrolled in the study and were divided into two homogeneous groups. No major or minor side effects were reported. In group 1, wrinkles, texture, static and dynamic crow's feet wrinkles improved significantly at 3 and 6 months. Patients were very satisfied at 3 months and satisfied at 6 months. In group 2, wrinkles and texture improved significantly at 3 months but did not improve at 6 months. Static and dynamic crow's feet wrinkles improved significantly at 1 and 3 months but did not improve significantly at 6 months.

CONCLUSIONS

Our prospective and randomized study has shown that the new TF is safe and effective in reducing superficial face wrinkles and producing dermal regeneration. It, therefore, prolongs the duration of the botulinum toxin. Further controlled study would be necessary to compare the new TF to neurotoxin treatment, or its action alone.

摘要

背景

一种新的基于 3 种主要提升成分的局部配方(TF)已被开发出来,用于减少面部浅表皱纹。

目的

确定这种新 TF 在减少面部浅表皱纹和重塑真皮基质方面的有效性。

方法

纳入年龄在 30-65 岁、有中度至重度鱼尾纹的女性。

排除标准

男性;年龄小于 30 岁或大于 65 岁;吸烟者。患者在鱼尾纹处接受 15IU 肉毒毒素和 2 种乳膏。50 名患者(第 1 组)应用 TP(产品 A),50 名(第 2 组)应用安慰剂(产品 B)。通过数字宏观摄影、Antera 3D 和患者满意度问卷进行评估。

结果

2019 年 4 月至 6 月,共纳入 100 名女性进行研究,并分为两组。未报告重大或轻微副作用。第 1 组的皱纹、纹理、静态和动态鱼尾纹在 3 个月和 6 个月时显著改善。患者在 3 个月时非常满意,在 6 个月时满意。第 2 组的皱纹和纹理在 3 个月时显著改善,但在 6 个月时无明显改善。静态和动态鱼尾纹在 1 个月和 3 个月时显著改善,但在 6 个月时无明显改善。

结论

我们的前瞻性和随机研究表明,新的 TF 安全有效,可减少面部浅表皱纹并产生真皮再生。因此,它延长了肉毒毒素的持续时间。需要进一步的对照研究来比较新的 TF 与神经毒素治疗或其单独作用。

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