A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type a for Injection (CU-20101)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

554

Participants

Timeline

Start Date

June 11, 2024

Primary Completion Date

March 1, 2026

Study Completion Date

May 1, 2026

Conditions
Glabellar Frown Lines
Interventions
DRUG

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)."

Trial Locations (1)

200443

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Cutia Therapeutics(Wuxi)Co.,Ltd

INDUSTRY

NCT06585696 - A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type a for Injection (CU-20101) | Biotech Hunter | Biotech Hunter