通用名称

clascoterone

儿科标签批准日期

2020/8/27 0:00:00

特定指示/秒

Acne vulgaris in patients 12 years of age and older

标签更改摘要

- Safety and effectiveness for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies. - Safety and effectiveness for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years. - Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed in 2/22 (9%) adolescent patients. All patients returned to normal HPA axis function at follow-up 4 weeks after stopping the treatment. Children may be more susceptible to systemic toxicity when treated with clascoterone. - Information on safety profile, PK and PD parameters, and clinical trials. - New drug.

治疗类别

Acne Agents

立法类型

PREA Only

产品说明书链接

书号

2.0 1.0

研究年龄

9 YEARS - 17 YEARS 9 YEARS - 17 YEARS

学习类型

Efficacy,Safety Efficacy,Safety

研究设计

Multicenter,Randomized,Double-Blind,Parallel Group,Vehicle Controlled Multicenter,Randomized,Double-Blind,Parallel Group,Vehicle Controlled

登记的患者

344 316

患者分析

N/A N/A

中心的数量

48 55

国家数量

6 3

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

N/A N/A

亚裔学生总数

N/A N/A

黑人总数

N/A N/A

白人总数

N/A N/A

夏威夷或太平洋岛民总数

N/A N/A

美洲印第安人/阿拉斯加本地人总数

N/A N/A

其他种族总计

N/A N/A

未知种族总数

N/A N/A

国家

United States,Bulgaria,Georgia,Poland,Romania,Serbia United States,Georgia,Ukraine