Abstract：
Traditional acne management with topical therapy, systemic antibiotics, hormonal agents, or oral isotretinoin requires compliance and may produce significant side effects. However, alternative treatments with lasers had failed to demonstrate durable clearance.
To assess the tolerability and therapeutic outcomes of a novel 1726 nm laser treatment of moderate-to-severe acne across skin types.
A prospective, open-label, single-arm, Investigational Device Exemption-approved, institutional review board-approved study of 104 subjects with moderate-to-severe facial acne and Fitzpatrick Skin Types ranging from II-to-VI was conducted. Subjects received 3 laser treatments at 3 (-1/+2)-week intervals.
Following final treatment, ≥50% reduction in active acne inflammatory lesions was 32.6% at 4-weeks follow-up, increasing further to 79.8% and 87.3% at 12 and 26-weeks, respectively. The percentage of subjects clear or almost clear increased from 0% at baseline to 9%, 36.0%, and 41.8% at 4-, 12-, and 26-weeks follow-up. No serious adverse events were observed related to device or protocol; treatments were well tolerated, requiring no anesthetic. Therapeutic outcomes and discomfort were similar across all skin types.
Lack of control group.
The study findings demonstrate the novel 1726 nm laser is well tolerated with durable progressive posttreatment improvement to at least 26 weeks for moderate-to-severe acne across skin types.
To assess the tolerability and therapeutic outcomes of a novel 1726 nm laser treatment of moderate-to-severe acne across skin types.
A prospective, open-label, single-arm, Investigational Device Exemption-approved, institutional review board-approved study of 104 subjects with moderate-to-severe facial acne and Fitzpatrick Skin Types ranging from II-to-VI was conducted. Subjects received 3 laser treatments at 3 (-1/+2)-week intervals.
Following final treatment, ≥50% reduction in active acne inflammatory lesions was 32.6% at 4-weeks follow-up, increasing further to 79.8% and 87.3% at 12 and 26-weeks, respectively. The percentage of subjects clear or almost clear increased from 0% at baseline to 9%, 36.0%, and 41.8% at 4-, 12-, and 26-weeks follow-up. No serious adverse events were observed related to device or protocol; treatments were well tolerated, requiring no anesthetic. Therapeutic outcomes and discomfort were similar across all skin types.
Lack of control group.
The study findings demonstrate the novel 1726 nm laser is well tolerated with durable progressive posttreatment improvement to at least 26 weeks for moderate-to-severe acne across skin types.
摘要：
背景：传统痤疮治疗与局部治疗，全身性抗生素，荷尔蒙剂，或口服异维A酸需要依从性，并可能产生明显的副作用。然而,激光治疗的替代疗法未能显示出持久的清除。
目的：评估新型1726-nm激光治疗不同皮肤类型的中度至重度痤疮的耐受性和治疗结果。
方法：前瞻性，开放标签，单臂,IDE批准,进行了IRB批准的104名患有中度至重度面部痤疮和Fitzpatrick皮肤类型从II至VI的受试者的研究。受试者以3(-1/+2)周的间隔接受三次激光治疗。
结果：最终治疗后，在4周随访时，活动性痤疮炎性病变减少≥50％，为32.6％，在12周和26周时进一步增加到79.8%和87.3%，分别。受试者清除或几乎清除的百分比从基线时的0%增加到9%，36.0%,和41.8%在4-，12周和26周随访。未观察到与装置或方案相关的严重不良事件；治疗耐受性良好，不需要麻醉.所有皮肤类型的治疗结果和不适相似。
结论：缺乏对照组。
结论：研究结果表明，新型1726nm激光对于不同皮肤类型的中度至重度痤疮具有良好的耐受性，治疗后至少26周的持续进行性改善。
目的：评估新型1726-nm激光治疗不同皮肤类型的中度至重度痤疮的耐受性和治疗结果。
方法：前瞻性，开放标签，单臂,IDE批准,进行了IRB批准的104名患有中度至重度面部痤疮和Fitzpatrick皮肤类型从II至VI的受试者的研究。受试者以3(-1/+2)周的间隔接受三次激光治疗。
结果：最终治疗后，在4周随访时，活动性痤疮炎性病变减少≥50％，为32.6％，在12周和26周时进一步增加到79.8%和87.3%，分别。受试者清除或几乎清除的百分比从基线时的0%增加到9%，36.0%,和41.8%在4-，12周和26周随访。未观察到与装置或方案相关的严重不良事件；治疗耐受性良好，不需要麻醉.所有皮肤类型的治疗结果和不适相似。
结论：缺乏对照组。
结论：研究结果表明，新型1726nm激光对于不同皮肤类型的中度至重度痤疮具有良好的耐受性，治疗后至少26周的持续进行性改善。
