554
Participants
Start Date
June 11, 2024
Primary Completion Date
March 1, 2026
Study Completion Date
May 1, 2026
CU-20101 treatment for Moderate to Severe Glabellar Striae
"Part I (randomized double-blind controlled study) Study Part 1 consisted of a 1-day baseline/treatment period (randomized and received 1 dose of study treatment) and a 12-week post-treatment follow-up period.~Part II (open-label study) For subjects who completed Part I of the study, they automatically entered Period 2 of the study. To evaluate the safety, efficacy, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar striae if they meet the criteria for repeat treatment (as shown in Figure 1, at least 12 weeks apart from each test drug injection). If repeat treatment criteria are not met at follow-up, follow-up may continue after 4 weeks until the next treatment is met. The last study treatment was no later than Day 253 ± 7 days (Week 36)."
Peking University First Hospital, Beijing
Lead Sponsor
Cutia Therapeutics(Wuxi)Co.,Ltd
INDUSTRY