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交联型和非交联型透明质酸联合肉毒毒素 A 治疗萎缩性痤疮瘢痕的疗效和安全性评价与比较:一项双盲随机临床试验。

Evaluation and comparison of the efficacy and safety of cross-linked and non-cross-linked hyaluronic acid in combination with botulinum toxin type A in the treatment of atrophic acne scars: A double-blind randomized clinical trial.

机构信息

Department of Dermatology, Rasool Akram Medical Complex Clinical Research Development Center (RCRDC), School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.

School of Medicine, Iran University of Medical Sciences (IUMS), Tehran, Iran.

出版信息

Skin Res Technol. 2024 Jan;30(1):e13541. doi: 10.1111/srt.13541.

Abstract

INTRODUCTION

Acne vulgaris is a common skin condition that affects a significant percentage of adolescents, with scarring being one of its permanent complications. This study aims to compare the efficacy and safety of using botulinum toxin type A (BTA) in combination with cross-linked and non-cross-linked hyaluronic acid (HA) for the treatment of atrophic acne scars.

METHOD

Our study is a randomized, double-blind clinical trial conducted on 16 patients with atrophic acne scars. The patients were randomly assigned to one of two groups: one group received a single session of BTA and crossed link HA combination, while the other group received two sessions of BTA and non-crossed link HA, 1 month apart. The patients were followed up at 3 and 6 months after baseline to evaluate the number and area of fine and large pores and spots, scar grading, patient satisfaction, and complications.

RESULTS

The mean age of individuals in both the cross-linked HA and non-cross-linked HA groups was 32.75 ± 4.26 and 31.50 ± 8.48 years, respectively (p = 0.71). In terms of gender, three (37.5%) and seven (87.5%) individuals in the cross-linked and non-cross-linked HA groups were female, respectively (p = 0.11). There were no significant differences in the count and area of fine and large pores and spots between the two groups at baseline and the first follow-up session. However, in the second follow-up session, the non-cross-linked HA group had significantly better results than the cross-linked HA group in terms of large pores count and area (p = 0.01). In terms of changes over time, the non-cross-linked HA group showed significantly better improvements in the count and area of large pores compared to the cross-linked HA group (p = 0.03). Additionally, both groups experienced a significant decrease in the count and area of fine pores over time (p = 0.001), but the amount of changes was not statistically significant between the two groups (p = 0.06). Concerning acne grade, initially, 62.5% and 12.5% of cases in the cross-linked HA and non-cross-linked HA groups, respectively, had severe grades. However, in the last session, these percentages significantly decreased to 0% for both groups (p = 0.002 and 0.005, respectively). In terms of treatment complications, none of the patients experienced any adverse effects.

CONCLUSION

The study demonstrated that both cross-linked HA and non-cross-linked HA were effective in reducing acne severity and improving the appearance of pores and spots. The treatments had similar effects on fine pores, spots, and overall acne severity. However, non-cross-linked HA appeared to have a better result on large pores compared to cross-linked HA.

摘要

简介

寻常痤疮是一种常见的皮肤疾病,影响着很大一部分青少年,其永久性并发症之一是瘢痕形成。本研究旨在比较使用肉毒毒素 A(BTA)联合交联和非交联透明质酸(HA)治疗萎缩性痤疮瘢痕的疗效和安全性。

方法

本研究是一项针对 16 名萎缩性痤疮瘢痕患者的随机、双盲临床试验。患者被随机分为两组:一组接受单次 BTA 和交联 HA 联合治疗,另一组接受两次 BTA 和非交联 HA 治疗,间隔 1 个月。患者在基线和第 3 个月、第 6 个月进行随访,以评估细小和粗大毛孔和斑点数量和面积、瘢痕分级、患者满意度和并发症。

结果

交联 HA 组和非交联 HA 组患者的平均年龄分别为 32.75±4.26 岁和 31.50±8.48 岁(p=0.71)。在性别方面,交联 HA 组和非交联 HA 组分别有 3 名(37.5%)和 7 名(87.5%)女性(p=0.11)。两组在基线和第 1 次随访时细小和粗大毛孔和斑点的数量和面积均无显著差异。然而,在第 2 次随访时,非交联 HA 组在粗大毛孔数量和面积方面的结果明显优于交联 HA 组(p=0.01)。就时间变化而言,非交联 HA 组在粗大毛孔数量和面积方面的改善明显优于交联 HA 组(p=0.03)。此外,两组的细小毛孔数量和面积均随时间显著减少(p=0.001),但两组之间的变化量无统计学差异(p=0.06)。关于痤疮分级,最初交联 HA 组和非交联 HA 组分别有 62.5%和 12.5%的病例为严重程度。然而,在最后一次随访时,两组的这一比例均显著下降至 0%(p=0.002 和 0.005)。关于治疗并发症,没有患者出现任何不良反应。

结论

本研究表明交联 HA 和非交联 HA 均可有效降低痤疮严重程度,改善毛孔和斑点的外观。两种治疗方法对细小毛孔、斑点和整体痤疮严重程度的效果相似。然而,非交联 HA 似乎在改善粗大毛孔方面优于交联 HA。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f25b/10765352/b9ff568726b7/SRT-30-e13541-g003.jpg

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