Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585696
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection CU-20101
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection CU-20101 Compared With A Single Treatment of Botox and Repeated Treatment of CU-20101 in Moderate to Severe Glabellar Striae
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 clinical study to evaluate the efficacy safety and immunogenicity of singlerepeated injections of CU-20101 in the treatment of moderate to severe glabellar lines The study consisted of a 7-day screening period Study Part 1 randomized double-blind controlled study and Period 2 open-label study Part I was a multicenter randomized double-blind single-injection active-drug parallel-controlled non-inferiority design clinical study to evaluate the efficacy safety and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox part 2 was an open-label study to evaluate the efficacy safety and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines
Detailed Description:
Part I randomized double-blind controlled study Study Part 1 consisted of a 1-day baselinetreatment period randomized and received 1 dose of study treatment and a 12-week post-treatment follow-up period It is proposed to enroll 554 subjects with moderate to severe glabellar lines Subjects eligible for inclusion were randomized in a 1 1 ratio to CU-20101 or Botox according to the stratification factors Stratification factors were severity of glabellar lines at baseline moderate vs severe when trying to frown as assessed on site by the investigator
After completing the dosing of Part I and assessments of relevant examinations subjects will return to the study site on Day 29 7 days Week 4 Day 57 7 days Week 8 and Day 85 7 days Week 12 for follow-up of efficacy safety and immunogenicity assessments Figure 1
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 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
Criteria for repeat therapy are all of the following criteria must be met 1The severity of glabellar lines was assessed by the investigator on-site when the subject tried to frown with an FWS score of 2 or 3 points 2The subjects self-assessed the severity of glabellar lines on the spot when they frowned with an FWS score of 2 or 3 3Meets the wishes of the subject 4All other inclusion criteria were met and none of the exclusion criteria were met
After completing the dosing of Part I and assessments of relevant examinations subjects will return to the study site on Day 29 7 days Week 4 Day 57 7 days Week 8 and Day 85 7 days Week 12 for follow-up of efficacy safety and immunogenicity assessments Figure 1
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 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
Criteria for repeat therapy are all of the following criteria must be met 1The severity of glabellar lines was assessed by the investigator on-site when the subject tried to frown with an FWS score of 2 or 3 points 2The subjects self-assessed the severity of glabellar lines on the spot when they frowned with an FWS score of 2 or 3 3Meets the wishes of the subject 4All other inclusion criteria were met and none of the exclusion criteria were met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None