Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
JAMA Facial Plast Surg. 2019 Mar 1;21(2):125-132. doi: 10.1001/jamafacial.2018.1404.
Evidence is robust for the effectiveness of microneedle therapy in the management of postacne atrophic scarring. A home-based topical treatment with an efficacy comparable to microneedling would be a useful addition in the armamentarium of acne scar management.
To compare the efficacy of topical tazarotene gel, 0.1%, with microneedling therapy in the management of moderate to severe atrophic acne scars.
DESIGN, SETTING, AND PARTICIPANTS: Prospective, observer-blinded, active-controlled, randomized clinical trial with 6 months of follow-up conducted between June 2, 2017, and February 28, 2018, at a tertiary care hospital in India. Thirty-six patients with grade 2 to 4 facial atrophic postacne scars and without a history of procedural treatment of acne scars within the previous year were recruited. Analyses were conducted using data from the evaluable population.
Both halves of each participant's face were randomized to receive either microneedling or topical tazarotene therapy. Microneedling was conducted on 1 side of the face with a dermaroller having a needle length of 1.5 mm for a total of 4 sessions during the course of 3 months. Participants were instructed to apply topical tazarotene gel, 0.1%, to the other side of the face once every night during this same period.
Patients were followed up at 3 and 6 months by a blinded observer, and improvements in acne scar severity based on Goodman and Baron quantitative and qualitative scores and a subjective independent dermatologist score (range, 0-10, with higher scores indicating better improvement) were assessed. Patient satisfaction was assessed using a patient global assessment score (ranging from 0 for no response to 10 for maximum improvement) at these follow-up visits.
There were 36 participants (13 men and 23 women; mean [range] age, 23.4 [18-30] years), and the median (interquartile range [IQR]) duration of acne was 6 (4-8) years. For the 34 participants included in the complete data analyses, the median (IQR) quantitative score for acne scar severity at the 6-month follow-up visit following treatment with either tazarotene (from a baseline of 8.0 [6.0-9.8] to 5.0 [3.0-6.0]) or microneedling (from a baseline of 7.0 [6.0-10.8] to 4.5 [3.0-6.0]) indicated significant improvement (P < .001) that was comparable for both treatments (median [IQR] change in severity score from baseline, 2.5 [2.0-4.0] vs 3.0 [2.0-4.0]; P = .42). By contrast, median qualitative acne scar scores were the same for both treatment groups at baseline and did not significantly change following either treatment.
The present clinical trial showed comparable outcomes of both treatments for the overall improvement of quantitative facial acne scar severity.
ClinicalTrials.gov identifier: NCT03170596.
重要性：有充分的证据表明微针疗法在治疗痤疮萎缩性瘢痕方面的有效性。一种具有类似微针功效的家用局部治疗方法将是痤疮瘢痕管理的有效补充手段。
目的：比较 0.1%他扎罗汀凝胶与微针疗法治疗中重度痤疮萎缩性瘢痕的疗效。
设计、地点和参与者：这是一项前瞻性、观察者盲法、活性对照、随机临床试验，于 2017 年 6 月 2 日至 2018 年 2 月 28 日在印度的一家三级保健医院进行，随访时间为 6 个月。共招募了 36 名面部 2 至 4 级的痤疮萎缩性瘢痕患者，且在过去 1 年内无痤疮瘢痕程序性治疗史。分析采用可评估人群的数据。
干预措施：每位参与者的一半面部随机接受微针或他扎罗汀治疗。微针治疗使用长度为 1.5 毫米的滚针在 3 个月的时间内共进行 4 次。在此期间，指导参与者每晚将 0.1%他扎罗汀凝胶涂抹在另一半面部。
主要结局和测量指标：在 3 个月和 6 个月时，由盲法观察者对患者进行随访，根据 Goodman 和 Baron 定量和定性评分以及独立皮肤科医生主观评分（范围 0-10，分数越高表示改善越好）评估痤疮瘢痕严重程度的改善情况。通过患者在这些随访时的整体评估评分（0 表示无反应，10 表示最大改善）评估患者满意度。
结果：共有 36 名参与者（13 名男性和 23 名女性；平均[范围]年龄为 23.4[18-30]岁），痤疮的中位（四分位间距[IQR]）持续时间为 6（4-8）年。在 34 名纳入完整数据分析的参与者中，接受他扎罗汀（基线时为 8.0[6.0-9.8]降至 5.0[3.0-6.0]）或微针（基线时为 7.0[6.0-10.8]降至 4.5[3.0-6.0]）治疗后 6 个月时的痤疮瘢痕严重程度定量评分中位数均有显著改善（P < .001），两种治疗方法的改善效果相当（中位数[IQR]基线严重程度评分变化，2.5[2.0-4.0]比 3.0[2.0-4.0]；P = .42）。相比之下，两组治疗组的基线时定性痤疮瘢痕评分相同，且在任何治疗后均无明显变化。
结论和相关性：本临床试验表明，两种治疗方法在改善面部痤疮瘢痕严重程度的整体定量方面具有相似的效果。
证据等级：1.
试验注册：ClinicalTrials.gov 标识符：NCT03170596.
