Glabellar Frown LinesPhase 3NCT06585696
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)
A Phase 3 study testing CU-20101 treatment for Moderate to Severe Glabellar Striae and BOTOX® in people with Glabellar Frown Lines, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- CU-20101 treatment for Moderate to Severe Glabellar Striae and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to 20 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria at the same time to be enrolled in the study:
- 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;
- Men or women aged 18-65 years (including boundary values);
- 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;
- Subjects self-assessed the severity of glabellar lines when trying to frown based on a 4-point FWS score ≥ 2 points;
- 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.
Who cannot join
- Subjects who met any of the following exclusion criteria were not eligible for enrollment into the study:
- Subjects with skin abnormalities, including active infections (e.g., herpes simplex, acne, etc.), skin diseases (e.g., psoriasis, eczema, etc.), scars, etc., which may interfere with the study assessment as judged by the investigator;
- Subjects with diseases that may affect neuromuscular function (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.); or previous history of epilepsy;
- Previous history of facial paralysis and ptosis;
- Significant facial asymmetry;
- Physical stretching methods (e.g., manual stroking of equality) do not reduce eyebrow lines;
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- Subjects allergic to the investigational product and its excipients (e.g., botulinum toxin, serum albumin, etc.);
- Subjects with prior surgery on the upper face (e.g. eyebrow lifting surgery), autologous fat implantation, semi-permanent or permanent material injection filling or implantation;
- Subjects who have received botulinum toxin injection of any serum type within 6 months prior to screening;
- Subjects who have received degradable fillers such as hyaluronic acid, collagen, etc. in the upper facial region within 12 months prior to screening;
- Subjects who have received intense pulsed light (photon), chemical denudation, etc., within 3 months prior to screening; for partial radiofrequency or high-energy laser treatment, the investigator should extend the interval to 6 months or more according to the actual situation;
- Subjects who plan to receive other medical aesthetic treatments (e.g., laser, injection tamponade, chemical peeling, etc.) or any treatment that may result in significant weight change (e.g. liposuction surgery, oral weight loss drugs, etc.) or who are expected to require treatment with botulinum toxin of any serum type (other than study intervention) during the study;
- Subjects taking oral retinoids within 6 months prior to screening or topical retinoids on the face within 3 months prior to screening;
- Subjects who have used the following systemic drugs within 1 month prior to screening: drugs with muscle relaxant effects (e.g., tubocurarine chloride, dantrolene sodium, baclofen, etc.), aminoglycoside antibiotics (e.g., gentamicin sulfate, neomycin sulfate, etc.), polypeptide antibiotics (e.g., polymyxin B sulfate), tetracycline antibiotics, lincolamides, anticholinergic drugs (e.g., hyoscine butylbromide hydrochloride, benzhexol hydrochloride, etc.), benzodiazepines (e.g., etizolam, etc.), benzamide drugs (e.g., thiopride hydrochloride, sulpiride, etc.);
- Subjects who have used anticoagulants or non-steroidal anti-inflammatory drugs within 7 days prior to study drug administration; for menstruating subjects, the study drug injection may be delayed as needed to avoid the menstrual period;
- Pregnant or lactating women;
- Male or female subjects unwilling to use reliable contraception throughout the trial (except female subjects of non-childbearing potential);
- According to vital signs, physical examination, 12-lead electrocardiogram, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation) and blood pregnancy test at screening, the investigator judged the abnormalities as clinically significant and assessed as not suitable for participation in the investigator;
- Positive results of any test result for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody;
- Participation in any clinical trial as a subject within 30 days prior to screening;
- Subjects with psychiatric disorders that may affect the conduct of the study as judged by the investigator;
- Previous history of drug or drug abuse;
- Subjects who are in the acute phase of disease at screening, or have serious systemic diseases, etc., and are judged by the investigator to be ineligible for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 200443
About this study
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
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.
Read the 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.
- Conditions
- Glabellar Frown Lines
- Being tested
- CU-20101 treatment for Moderate to Severe Glabellar Striae, BOTOX®
- Keywords
- CU-20101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU-20101 treatment for Moderate to Severe Glabellar StriaeDrug
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.
BOTOX®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Botox® | Active comparator | Botox® treatment for Moderate to Severe Glabellar Striae Receives: Drug: BOTOX® |
| CU-20101 | Experimental | CU-20101 treatment for Moderate to Severe Glabellar Striae Receives: Drug: CU-20101 treatment for Moderate to Severe Glabellar Striae |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
- 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start24 Jun 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel +Single Group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Wu, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585696
- Sponsor's protocol ID
- CU-20101-305
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06585696
- Acronym / sponsor ID
- CU-20101-305
- Conditions
- Glabellar Frown Lines
- Keywords
- CU-20101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel +Single Group
| Arm | Type | Receives |
|---|---|---|
| Botox® | Active comparator | Drug: BOTOX®Botox® treatment for Moderate to Severe Glabellar Striae |
| CU-20101 | Experimental | Drug: CU-20101 treatment for Moderate to Severe Glabellar StriaeCU-20101 treatment for Moderate to Severe Glabellar Striae |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria at the same time to be enrolled in the study:
Key exclusion criteria (23 listed)
- Subjects who met any of the following exclusion criteria were not eligible for enrollment into the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CU-20101 treatment for Moderate to Severe Glabellar StriaeDrug: 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. | Drug | CU-20101 |
| BOTOX®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. | Drug | Botox® |
Primary outcome
• 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wu, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CU-20101 treatment for Moderate to Severe Glabellar Striae and BOTOX® in people with Glabellar Frown Lines, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.