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研究添加 Profhilo 中胚凝胶与单纯皮下分离术治疗痤疮瘢痕的影响:一项单盲、劈裂面部随机试验。

Investigating the impact of added Profhilo mesogel to subcision versus subcision monotherapy in treating acne scars; a single-blinded, split-face randomized trial.

机构信息

Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.

Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Cosmet Dermatol. 2024 Jun;23(6):1992-2000. doi: 10.1111/jocd.16258. Epub 2024 Mar 1.

Abstract

BACKGROUND

Acne scar is an inflammatory condition, which commonly occurs in patients with acne vulgaris, especially in adults. Mesogels have been reported effective in improving atrophic acne scars.

AIMS

We investigated the efficacy of adding Profhilo (a hyaluronic acid-based filler) to subcision as a new treatment method.

METHODS

Twelve patients aged 18-45 years with atrophic acne scars on both sides of the face participated in this single-blinded, split-face, randomized controlled trial. Each side of the face was randomly assigned to one of the treatment methods, including subcision alone and subcision + Profhilo. Patients in the Profhilo arm received mesogel (1 cc) in addition to the subcision procedure. Both methods were carried out two times at 1-month intervals. Assessments were done based on the sonographic depth of scars, and two blinded observers examined photographs at baseline and 3 months after the final session and the results were reported based on an exclusively made formula as the total score. The Global Improvement Scale and Visual Analogue Scale (VAS) (for patient satisfaction) were also used.

RESULTS

The VAS score of patient satisfaction was statistically significant in the Profhilo arm, with a mean improvement of 528.08 and 219.06 in the subcision arm (p = 0.02). No significant difference was seen in total acne scar reduction comparing the two methods (29.74 in the Profhilo arm and 22.27 in the subcision arm, p = 0.56). Sonographic depth reduction was also non-significant, with a mean of 29.21 in the Profhilo arm and 28.53 in the subcision arm (p = 0.4). The mean global improvement was reported as four in both arms, and no statistical significance was observed (p = 0.89). The best response to treatment belonged to the rolling subtype in both methods (p = 0.029 for the Profhilo arm and p = 0.001 for the subcision arm).

CONCLUSION

Despite no significant difference between the methods, Profhilo is more effective due to a higher satisfaction rate and better physiologic effects.

摘要

背景

痤疮瘢痕是一种炎症性疾病,常见于寻常痤疮患者,尤其在成年人中。中胚层疗法已被报道可有效改善萎缩性痤疮瘢痕。

目的

我们旨在研究在皮下分离术的基础上添加 Profhilo(一种基于透明质酸的填充剂)作为一种新的治疗方法的疗效。

方法

本单盲、分割面部、随机对照试验纳入了 12 名年龄在 18-45 岁之间、面部两侧均有萎缩性痤疮瘢痕的患者。每侧面部随机分配到以下两种治疗方法之一,包括单独皮下分离术和皮下分离术+Profhilo。Profhilo 组患者除皮下分离术外还接受 1cc 中胚层疗法。两种方法均在 1 个月的间隔内进行两次。根据瘢痕的超声深度进行评估,两位盲法观察者在基线和最后一次治疗后 3 个月检查照片,并根据专门制定的公式报告总评分作为结果。还使用了整体改善量表和视觉模拟量表(VAS)(用于患者满意度)。

结果

Profhilo 组患者的 VAS 评分满意度具有统计学意义,皮下分离术组的平均改善为 528.08,Profhilo 组为 219.06(p=0.02)。两种方法比较,总痤疮瘢痕减少无显著差异(Profhilo 组为 29.74,皮下分离术组为 22.27,p=0.56)。超声深度减少也无显著差异,Profhilo 组为 29.21,皮下分离术组为 28.53(p=0.4)。两组的平均整体改善均为 4 分,无统计学差异(p=0.89)。两种方法的最佳治疗反应均属于滚动型(Profhilo 组为 p=0.029,皮下分离术组为 p=0.001)。

结论

尽管两种方法之间无显著差异,但 Profhilo 由于具有更高的满意度和更好的生理效果,因此更有效。

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