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一种用于治疗痤疮疤痕的针刺设备的疗效:一项随机临床试验。

Efficacy of a needling device for the treatment of acne scars: a randomized clinical trial.

机构信息

Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois2Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois3Department of Surgery, Feinberg School of Medicine, No.

Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

出版信息

JAMA Dermatol. 2014 Aug;150(8):844-9. doi: 10.1001/jamadermatol.2013.8687.

Abstract

IMPORTANCE

Neocollagenesis can be achieved using a dermal rolling needle device, thereby reducing the appearance of acne scars.

OBJECTIVE

To determine the efficacy of a needling device for treatment of acne scars.

DESIGN, SETTING, AND PARTICIPANTS: We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. The study took place from November 30, 2009, through July 27, 2010. Twenty healthy adults (age range, 20-65 years) with acne scars on both sides of the face were enrolled. Fifteen individuals completed the study, and no enrolled participants were withdrawn for adverse effects.

INTERVENTIONS

For each participant, one side of the face was randomized for needling. Three needling treatments were performed at 2-week intervals.

MAIN OUTCOMES AND MEASURES

Two blinded dermatologists separately rated participants' acne scars based on standard digital photographs obtained at baseline and at the 3-month and 6-month follow-up visits on the quantitative global scarring grading system.

RESULTS

Mean scar scores were significantly lower in the treatment group compared with baseline at 6 months (mean difference, 3.4; 95% CI, 0.2-6.5; P = .03) and nominally but not significantly lower compared with baseline at 3 months (mean difference, 2.4; 95% CI, -0.01 to 4.8; P = .052). In the control group, mean scar scores did not vary significantly from baseline at 3 months (mean difference, 1.0; 95% CI, -1.4 to 3.4; P = .96) and at 6 months (mean difference, 0.4; 95% CI, -2.3 to 3.5; P > .99). The needling procedure was not particularly painful, with a mean pain rating of 1.08 of 10. Participants perceived a 41% mean improvement in overall scar appearance on the treated side. No adverse events were reported.

CONCLUSIONS AND RELEVANCE

After 3 needling treatments, there was improvement in the appearance of acne scars over time compared with the control group, with minimal pain reported.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00974870.

摘要

重要性

使用真皮滚针装置可以实现新胶原生成,从而减少痤疮疤痕的外观。

目的

确定一种用于治疗痤疮疤痕的针具的疗效。

设计、地点和参与者:我们在一家城市学术机构进行了一项单中心、评分者盲法、平衡(1:1)、分割面、安慰剂对照、平行组随机临床试验。该研究于 2009 年 11 月 30 日至 2010 年 7 月 27 日进行。共有 20 名健康成年人(年龄 20-65 岁)参加了这项研究,他们的面部两侧都有痤疮疤痕。15 名参与者完成了研究,没有参与者因不良反应而退出。

干预措施

对于每位参与者,一侧面部随机接受针刺治疗。每隔 2 周进行 3 次针刺治疗。

主要结果和测量指标

两位盲法皮肤科医生分别根据标准数字照片,对参与者在基线、3 个月和 6 个月随访时的痤疮疤痕进行评分,使用定量整体疤痕分级系统进行评估。

结果

治疗组的疤痕评分在 6 个月时明显低于基线(平均差异为 3.4;95%置信区间为 0.2-6.5;P = .03),在 3 个月时略低于基线(平均差异为 2.4;95%置信区间为-0.01 至 4.8;P = .052),但无统计学意义。在对照组中,3 个月时疤痕评分与基线相比无显著差异(平均差异为 1.0;95%置信区间为-1.4 至 3.4;P = .96),6 个月时也无显著差异(平均差异为 0.4;95%置信区间为-2.3 至 3.5;P >.99)。针刺过程并不特别疼痛,平均疼痛评分为 10 分中的 1.08 分。参与者认为治疗侧的整体疤痕外观改善了 41%。没有报告不良反应。

结论和相关性

与对照组相比,经过 3 次针刺治疗后,痤疮疤痕的外观随时间改善,报告的疼痛程度最小。

试验注册

clinicaltrials.gov 标识符:NCT00974870。

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