Moderate to Severe Glabellar LinesPhase 3NCT06583486
A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
A Phase 3 study testing Rcombinant botulinum neurotoxin type A for injection (YY001) in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 16 sites in China.
Trial summary
This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection 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
- Moderate to Severe Glabellar Lines
- What is being tested?
- Rcombinant botulinum neurotoxin type A for injection (YY001)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 16 sitesChina
- Study dates
- 19 Mar 2024to 25 Aug 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
- Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
- At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
- Agree to participate in the study and sign the informed consent form.
- At the discretion of the investigator, the participants can comply with the protocol requirements.
- Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug.
- Note:
- Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
- Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones [oral, patch, ring, injections, implants], barrier methods [diaphragm, cervical cap, sponge, condom].
Who cannot join
- Use of medications or treatments prohibited by the REFINE study protocol.
- Any condition that required permanent discontinuation of study treatment during the REFINE study.
- Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
- Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN.
- Female who is pregnant or breast feeding.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Tsinghua Changgung Hospital
Beijing
Peking Union Medical College Hospital , Chinese Academy of Medical Sciences
Beijing
Peking University First Hospital
Beijing
Peking University Third Hospital
Beijing
Plastic Surgery Hospital, Chinese Academy of Medical Science
Beijing
The Third Xiangya Hospital of Central South University
Changsha, Hunan
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan
Guangdong Second People's Hospital
Guangzhou, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Chongqing Medical University
Hongqing
Tianjin Medical University General Hospital
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xian, Shanxi
About this study
Official title: A Multi-center, Open-label Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- Rcombinant botulinum neurotoxin type A for injection (YY001)
- Keywords
- YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rcombinant botulinum neurotoxin type A for injection (YY001)Biological
Five sites will be injected at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Five sites will be repeatedly injected with Rcombinant botulinum neurotoxin type A for injection (YY001) at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.The study period is up to 64 weeks, divided into 5 treatment cycles. Receives: Biological: Rcombinant botulinum neurotoxin type A for injection (YY001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events and drug-related adverse events during the study.
Measured: Up to 64 weeks
Secondary outcomes (6)
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.
Glabellar lines at maximal frown are based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
Measured: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
Measured: At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The respond rate on the investigator's assessment of GL severity at maximal frown.
The respond rate: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from the baseline, on the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.
Measured: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest.
The severity of glabellar lines at rest will be assessed according to the 4 grade scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
Measured: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
Incidence of anti-drug antibodies and neutralizing antibodies during the study.
Measured: Up to 64 weeks
The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline.
Measured: Up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start19 Mar 2024
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm and long-term follow-up
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Wu, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583486
- Sponsor's protocol ID
- YY001-001-Ⅲ-RENEW
- Other IDs
- CTR20240641
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2024
- Last updated
- 29 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06583486
- Acronym / sponsor ID
- YY001-001-Ⅲ-RENEW
- Conditions
- Moderate to Severe Glabellar Lines
- Keywords
- YY001, Recombinant Botulinum Toxin Type A, Botulinum Toxin, Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 4 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 Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm and long-term follow-up
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Rcombinant botulinum neurotoxin type A for injection (YY001)Five sites will be repeatedly injected with Rcombinant botulinum neurotoxin type A for injection (YY001) at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.The study period is up to 64 weeks, divided into 5 treatment cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
- At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
- Agree to participate in the study and sign the informed consent form.
- At the discretion of the investigator, the participants can comply with the protocol requirements.
- Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug.
Key exclusion criteria (5 listed)
- Use of medications or treatments prohibited by the REFINE study protocol.
- Any condition that required permanent discontinuation of study treatment during the REFINE study.
- Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
- Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN.
- Female who is pregnant or breast feeding.
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 |
|---|---|---|
| Rcombinant botulinum neurotoxin type A for injection (YY001)Five sites will be injected at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U. | Biological | Treatment Group |
Primary outcome
Incidence of serious adverse events and drug-related adverse events during the study.
Time frame: Up to 64 weeks
6 secondary outcomes
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.
Time frame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
Time frame: At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The respond rate on the investigator's assessment of GL severity at maximal frown.
Time frame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest.
Time frame: At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.
Incidence of anti-drug antibodies and neutralizing antibodies during the study.
Time frame: Up to 64 weeks
The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline.
Time frame: Up to 64 weeks
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 29 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 principal investigator
Peking University First Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rcombinant botulinum neurotoxin type A for injection (YY001) in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 16 sites 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 8 inclusion and 5 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 29 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 16 sites 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?
Incidence of serious adverse events and drug-related adverse events during the study. (time frame: Up to 64 weeks). 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 29 Jun 2026.