Jackson J Mark, Coulon Rick, Arbiser Jack L
J Drugs Dermatol. 2021 Jun 1;20(6):660-664. doi: 10.36849/JDD.2021.5925.
Novel, effective, affordable therapies for rosacea are needed. Innovative methods of assessing response for rosacea treatments are needed as well. This trial was designed to evaluate efficacy and safety of ACU-D1, a novel inhibitor of the 26S protea-some for the treatment of moderate to severe rosacea in a first in human pilot study. In addition, this is the first trial to our knowledge to use Canfield imaging to quantitatively assess responses.
This was a 14-week, randomized, double-blinded, placebo-controlled study, performed at two well established rosacea clini-cal trial sites, which randomized 40 adult subjects with moderate to severe rosacea (Investigator’s Global Assessment [IGA]=3/4) to either ACU-D1 (27) or comparator vehicle (13) twice daily. In addition, Canfield imaging was used to assess responses both qualitatively and quantitatively Results: A total of 39 subjects participated, with 38 completing the study. ACU-D1 displayed efficacy in 92% (25 of 27) of patients in reducing inflammatory lesions and a 2 plus grade IGA reduction of clear to near clear in 27% of patients. There was a trend toward improvement in erythema as well in the active arm.
This study demonstrates that topical ACU-D1 is safe and well-tolerated by patients in the study and demonstrates efficacy in reducing inflammatory lesions and erythema in patients with rosacea. Improvement was also noted on Canfield imaging, and this modality is likely to be used as an objective measure in the future. Further studies are warranted based on these initial positive results. ClinicalTrials.gov Identifier: NCT03064438 J Drugs Dermatol. 2021;20(6):660-664. doi:10.36849/JDD.5925.
需要针对酒渣鼻的新型、有效且价格合理的疗法。还需要评估酒渣鼻治疗反应的创新方法。本试验旨在评估ACU-D1（一种新型26S蛋白酶体抑制剂）在首次人体试点研究中治疗中度至重度酒渣鼻的疗效和安全性。此外，据我们所知，这是首次使用Canfield成像进行定量评估反应的试验。
这是一项为期14周的随机、双盲、安慰剂对照研究，在两个成熟的酒渣鼻临床试验地点进行，将40名中度至重度酒渣鼻成年受试者（研究者整体评估[IGA]=3/4）随机分为两组，分别每日两次使用ACU-D1（27例）或对照赋形剂（13例）。此外，使用Canfield成像进行定性和定量评估反应。结果：共有39名受试者参与，38名完成研究。ACU-D1在92%（27例中的25例）的患者中显示出减少炎性皮损的疗效，27%的患者IGA降低2级且从明显改善至接近清除。治疗组的红斑也有改善趋势。
本研究表明，局部使用ACU-D1在研究中对患者是安全且耐受性良好的，并且在减少酒渣鼻患者的炎性皮损和红斑方面显示出疗效。Canfield成像也显示有改善，这种方法未来可能会用作客观测量方法。基于这些初步的阳性结果，有必要进行进一步研究。ClinicalTrials.gov标识符：NCT03064438。《药物皮肤病学杂志》。2021年；20(6):660 - 664。doi:10.36849/JDD.5925。
