Glabellar Frown Lines
Conditions
Keywords
CU-20101
Brief summary
This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated 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 baseline/treatment 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): 1.The 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; 2.The subjects self-assessed the severity of glabellar lines on the spot when they frowned with an FWS score of 2 or 3; 3.Meets the wishes of the subject; 4.All other inclusion criteria were met and none of the exclusion criteria were met.
Interventions
DRUGCU-20101 treatment for Moderate to Severe Glabellar Striae
Drug: CU-20101 treatment for Moderate to Severe Glabellar Striae Part I comprised a single-day baseline and treatment phase, in which subjects were randomized to receive one dose of investigational product, followed by a 12-week post-treatment follow-up period.For Arm "CU-20101", the arm should recept "CU-20101" assigned to it. All subjects who completed Part I will progressed into Part II. This open-label phase aimed to assess the safety, efficacy and immunogenicity of repeated CU-20101 injections for moderate-to-severe glabellar frown lines. Re-treatment was permitted only when predefined retreatment criteria were satisfied, with a minimum 12-week interval between consecutive investigational product injections. If retreatment criteria were not fulfilled at a scheduled follow-up visit, subjects would continue follow-up assessments at 4-week intervals until eligibility for repeat injection was met. The final study treatment was administered no later than Day 253 ±7 days.
DRUGBOTOX®
Drug: Botox® treatment for Moderate to Severe Glabellar Striae Part I comprised a single-day baseline and treatment phase, in which subjects were randomized to receive one dose of investigational product, followed by a 12-week post-treatment follow-up period. For Arm "Botox®", the arm should receipt "Botox®" assigned to it.
Sponsors
Cutia Therapeutics（Wuxi）Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel +Single Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all of the following inclusion criteria at the same time to be enrolled in the study: 1. After being fully informed, fully aware of the content, process, benefits and possible adverse reactions of the study, and voluntarily participate in the study, and sign the informed consent form; 2. Men or women aged 18-65 years (including boundary values); 3. At screening, the investigator assessed the severity of glabellar lines when the subject tried to frown based on a 4-point FWS, with a score of ≥ 2 points; 4. Subjects self-assessed the severity of glabellar lines when trying to frown based on a 4-point FWS score ≥ 2 points; 5. Subjects were able to communicate well with the investigator and were willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
* Subjects who met any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection. | Stage 1: Screening period of 7 days, treatment + follow-up about 12 weeks, the longest 92 days; Stage 2: Treatment + follow-up for about 36 weeks. All together takes up to 344 days | • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYan Wu, PhD
Peking University First Hospital
Outcome results
None listed