J Drugs Dermatol. 2021 Apr 1;20(4):426-431. doi: 10.36849/JDD.2021.5923.
Cutaneous rosacea is a common inflammatory skin disorder that often presents with facial papulopustular lesions that are frequently bothersome to patients. Studies have shown oral sarecycline to be effective and safe for acne, with a low risk of side effects that are historically associated with other tetracycline-class drugs such as doxycycline and minocycline, in addition to offering a reduced risk of emergence of resistant bacteria due to its narrow-spectrum of antibiotic activity. Oral sarecycline is FDA-approved for the treatment of acne (2018).
A pilot study to evaluate the efficacy and safety of oral sarecycline in papulopustular rosacea.
A 12-week, prospective, parallel-group, investigator-blinded, controlled pilot study was completed evaluating once-daily sarecycline, using weight-based oral dosing as recommended for acne vs control (multivitamin tablet), for the treatment of moderate-to-severe papulopustular rosacea in adult subjects (n=102), aged ≥18 years. The primary efficacy endpoint was Investigator’s Global score (IGA; clear or almost clear) and percent reduction in inflammatory lesion count at week 12. Safety and tolerability assessments were performed as well.
A total of 102 subjects were randomized; 97 completed the study. At week 12, IGA improvement was significantly greater for oral sarecycline when compared to the control (P<0.0001). Furthermore, absolute and percent reductions in inflammatory lesion counts were significantly greater in the sarecycline group for all weeks (4, 8, and 12) when compared to the control (P<0.001). Significant improvement in facial burning, erythema, and pruritus was reported in the sarecycline group, when compared to the control (P<0.05). No serious AEs were reported.
Sarecycline was effective, safe, and well-tolerated for treating papulopustular rosacea in adults with marked superiority in efficacy compared to subjects in the control group. With its narrow-spectrum activity, oral sarecycline may be a good option for the treatment of papulopustular rosacea. Additional studies are warranted to confirm the positive results of this pilot study.
酒渣鼻是一种常见的炎症性皮肤疾病，常表现为面部丘疹脓疱性皮损，常给患者带来困扰。研究表明，口服沙瑞环素治疗痤疮有效且安全，副作用风险低，与多西环素和米诺环素等其他四环素类药物相比，此外，由于其窄谱抗生素活性，出现耐药菌的风险降低。口服沙瑞环素于 2018 年获美国食品和药物管理局批准用于治疗痤疮。
评估口服沙瑞环素治疗丘疹脓疱性酒渣鼻的疗效和安全性。
完成了一项为期 12 周、前瞻性、平行组、研究者设盲、对照的试点研究，评估了每日一次的沙瑞环素（根据推荐的痤疮剂量，按体重口服）与对照（多种维生素片）治疗成人（n=102）中度至重度丘疹脓疱性酒渣鼻的疗效，年龄≥18 岁。主要疗效终点为研究者整体评分（IGA；清除或几乎清除）和第 12 周时炎症性皮损计数的百分比降低。还进行了安全性和耐受性评估。
共有 102 名受试者被随机分配；97 名完成了研究。第 12 周时，与对照组相比，口服沙瑞环素的 IGA 改善显著更大（P<0.0001）。此外，与对照组相比，沙瑞环素组的炎症性皮损计数绝对和百分比降低在所有周（4、8 和 12）均显著更大（P<0.001）。与对照组相比，沙瑞环素组报告的面部烧灼感、红斑和瘙痒显著改善（P<0.05）。未报告严重不良事件。
沙瑞环素对治疗成人丘疹脓疱性酒渣鼻有效、安全且耐受良好，与对照组相比具有明显的疗效优势。口服沙瑞环素具有窄谱活性，可能是治疗丘疹脓疱性酒渣鼻的一个不错选择。需要进一步的研究来证实这项试点研究的积极结果。
