Abstract：
Molluscum contagiosum (MC) is a highly contagious skin condition. Lesions may persist for months to years, and no US Food and Drug Administration-approved medications are currently available in the US.
To assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of MC.
This was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted MC or with MC only in the periocular area were excluded.
Patients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks.
The primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021.
A total of 891 participants were randomized, 444 to berdazimer, 10.3% (mean [range] age, 6.6 [0.9-47.5] years; 228 [51.4%] male; 387 [87.2%] White individuals), and 447 to vehicle (mean [range] age, 6.5 [1.3-49.0] years; 234 [52.3%] female; 382 [85.5%] White individuals). In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% (397 patients) in the vehicle group had a lesion count performed at week 12. At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8; P < .001) with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of MC clearance compared with 8.9% (40 patients) of the vehicle group. Adverse event rates were low. The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group. The most common local skin reaction was mild to moderate erythema.
Use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates.
ClinicalTrials.gov Identifier: NCT04535531.
To assess the efficacy and safety of berdazimer gel, 10.3%, a novel topical nitric oxide-releasing medication, in the treatment of MC.
This was a multicenter, vehicle-controlled, double-blind, phase 3 randomized clinical trial (B-SIMPLE4) conducted in 55 clinics (mostly dermatology and pediatric) in the US from September 1, 2020, to July 21, 2021. Eligible participants were 6 months or older and had from 3 to 70 raised MC lesions. Patients with sexually transmitted MC or with MC only in the periocular area were excluded.
Patients were randomized to treatment with berdazimer gel, 10.3%, or vehicle gel, applied as a thin layer to all lesions once daily for 12 weeks.
The primary efficacy end point was complete clearance of all MC lesions at week 12. Safety and tolerability measures included adverse event frequency and severity, and assessment of local skin reactions and scarring. Data analyses were performed from August 31, 2021, to September 14, 2021.
A total of 891 participants were randomized, 444 to berdazimer, 10.3% (mean [range] age, 6.6 [0.9-47.5] years; 228 [51.4%] male; 387 [87.2%] White individuals), and 447 to vehicle (mean [range] age, 6.5 [1.3-49.0] years; 234 [52.3%] female; 382 [85.5%] White individuals). In the intention-to-treat population, 88.5% (393 patients) in the berdazimer group and 88.8% (397 patients) in the vehicle group had a lesion count performed at week 12. At week 12, 32.4% (144 patients) in the berdazimer group achieved complete clearance of MC lesions compared with 19.7% (88 patients) in the vehicle group (absolute difference, 12.7%; odds ratio, 2.0; 95% CI, 1.5-2.8; P < .001) with 14.4% (64 patients) of the berdazimer group discontinuing treatment because of MC clearance compared with 8.9% (40 patients) of the vehicle group. Adverse event rates were low. The most common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% (18 patients) of the berdazimer group and 0.7% (3 patients) of the vehicle group. The most common local skin reaction was mild to moderate erythema.
Use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates.
ClinicalTrials.gov Identifier: NCT04535531.
摘要：
传染性软疣（MC）是一种高度传染性的皮肤疾病。病变可能会持续数月至数年，美国目前没有美国食品和药物管理局批准的药物。
为了评估Berdazimer凝胶的疗效和安全性，10.3%,一种新型的局部一氧化氮释放药物，在MC的治疗中。
这是一个多中心,车辆控制,双盲,3期随机临床试验(B-SIMPLE4)于2020年9月1日至2021年7月21日在美国55家诊所(主要是皮肤科和儿科)进行.符合条件的参与者为6个月或更大，并且有3至70个凸起的MC病变。排除性传播MC或仅在眼周区域有MC的患者。
患者被随机分配到Berdazimer凝胶治疗，10.3%,或载体凝胶，作为薄层应用于所有病变，每天一次，持续12周。
主要疗效终点是在第12周时所有MC病变的完全清除。安全性和耐受性措施包括不良事件的频率和严重程度，并评估局部皮肤反应和疤痕。数据分析从2021年8月31日至2021年9月14日进行。
共有891名参与者被随机分组，444给berdazimer，10.3%(平均[范围]年龄，6.6[0.9-47.5]岁；228[51.4%]男性；387[87.2%]白人），和447到车辆(平均[范围]年龄，6.5[1.3-49.0]岁；234[52.3％]女性；382[85.5％]白人）。在意向治疗人群中，Berdazimer组中的88.5％（393名患者）和媒介物组中的88.8％（397名患者）在第12周进行了病变计数。在第12周，berdazimer组中的32.4％（144例患者）实现了MC病变的完全清除，而媒介物组中的19.7％（88例患者）（绝对差异，12.7%；赔率比，2.0；95％CI，1.5-2.8；P<.001），其中Berdazimer组的14.4％（64名患者）因MC清除而中断治疗，而媒介物组为8.9％（40名患者）。不良事件发生率较低。最常见的不良事件是应用部位疼痛和红斑，大多是轻微的严重程度。导致停药的不良事件影响了Berdazimer组的4.1％（18名患者）和媒介物组的0.7％（3名患者）。最常见的局部皮肤反应是轻度至中度红斑。
使用berdazimer凝胶，10.3%,对于MC似乎显示出良好的疗效和安全性,且不良事件发生率低.
ClinicalTrials.gov标识符：NCT04535531。
为了评估Berdazimer凝胶的疗效和安全性，10.3%,一种新型的局部一氧化氮释放药物，在MC的治疗中。
这是一个多中心,车辆控制,双盲,3期随机临床试验(B-SIMPLE4)于2020年9月1日至2021年7月21日在美国55家诊所(主要是皮肤科和儿科)进行.符合条件的参与者为6个月或更大，并且有3至70个凸起的MC病变。排除性传播MC或仅在眼周区域有MC的患者。
患者被随机分配到Berdazimer凝胶治疗，10.3%,或载体凝胶，作为薄层应用于所有病变，每天一次，持续12周。
主要疗效终点是在第12周时所有MC病变的完全清除。安全性和耐受性措施包括不良事件的频率和严重程度，并评估局部皮肤反应和疤痕。数据分析从2021年8月31日至2021年9月14日进行。
共有891名参与者被随机分组，444给berdazimer，10.3%(平均[范围]年龄，6.6[0.9-47.5]岁；228[51.4%]男性；387[87.2%]白人），和447到车辆(平均[范围]年龄，6.5[1.3-49.0]岁；234[52.3％]女性；382[85.5％]白人）。在意向治疗人群中，Berdazimer组中的88.5％（393名患者）和媒介物组中的88.8％（397名患者）在第12周进行了病变计数。在第12周，berdazimer组中的32.4％（144例患者）实现了MC病变的完全清除，而媒介物组中的19.7％（88例患者）（绝对差异，12.7%；赔率比，2.0；95％CI，1.5-2.8；P<.001），其中Berdazimer组的14.4％（64名患者）因MC清除而中断治疗，而媒介物组为8.9％（40名患者）。不良事件发生率较低。最常见的不良事件是应用部位疼痛和红斑，大多是轻微的严重程度。导致停药的不良事件影响了Berdazimer组的4.1％（18名患者）和媒介物组的0.7％（3名患者）。最常见的局部皮肤反应是轻度至中度红斑。
使用berdazimer凝胶，10.3%,对于MC似乎显示出良好的疗效和安全性,且不良事件发生率低.
ClinicalTrials.gov标识符：NCT04535531。
