Moderate to Severe Glabellar LinesPhase 3NCT06499688
A Phase III Study to Evaluate the Efficacy and Safety of 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) and OnabotulinumtoxinA 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 randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin type A for injection (YY001)) 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) and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 529 participants
- Where
- 16 sitesChina
- Study dates
- 28 Dec 2023to 31 May 2024
- 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 and baseline, moderate to severe glabellar lines (grade of 2 or 3 on the 4-point Scale) at maximal frown as assessed by both the Investigator and the participant on-site.
- 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 administration of study drug or a urine pregnancy test examination must be negative 3 days prior to the 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
- Known allergy to any component of the test product (includes investigational product and comparator product), or hypersensitivity.
- Previous cosmetic manipulation of the area between the eyebrows, within 12 months prior to screening; implantation of autologous fat or any permanent material; history of upper face lifting or semi-permanent prosthetic fillers, etc.; or plan to undergo upper face cosmetic manipulation during the study period (note: except for study drug injections);
- Use of any botulinum toxin within 6 months prior to baseline, or planned use of botulinum toxin during the study (note: except for use of investigational drugs at the study site).
- Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants (e.g., heparin, coumarins, non-vitamin K antagonists, oral anticoagulants within 1 week prior to baseline.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to baseline, including but not limited to: muscarinic agents, aminoglycosides, anticholinergic agents, benzodiazepines.
- At screening and baseline, skin abnormalities at the injection site
Show all 14Show fewer
- Inability to substantially lessen glabellar lines by physically spreading them apart, as determined by the investigator.
- Ptosis, significant facial asymmetry, excessive skin laxity at screening or baseline, or a history of any of the above.
- A history of facial nerve palsy.
- History or presence of such diseases that interfere with neuromuscular function, including, but not limited to: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis; diseases or a history of such diseases that can cause localized neuromuscular function, including, but not limited to: swallowing/breathing difficulties, diplopia, angle-closure glaucoma, significant drooping of the eyes and eyebrows, or flaccidity of the skin/excessive weakness or weakness of the corrugate and/or procerus;
- Have other concomitant diseases, including but not limited to cardiovascular, respiratory, gastrointestinal, endocrine, and other systemic diseases, malignant tumors, and immunodeficiencies, which are assessed by the investigator to be unsuitable for participation in clinical research.
- History of drug or alcohol abuse.
- History or presence of epilepsy.
- 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, Tan
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing
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
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 Randomized, Double-blind, Placebo- and Active-controlled Parallel-group Multi-center Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
This is a randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin 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), OnabotulinumtoxinA, Placebo
- 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
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
OnabotulinumtoxinABiological
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
PlaceboBiological
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single injection with Rcombinant botulinum neurotoxin type A for injection(YY001) in glabellar lines Receives: Biological: Rcombinant botulinum neurotoxin type A for injection (YY001) |
| Active-Controlled Group | Active comparator | Single injection with BOTOX® in glabellar lines Receives: Biological: OnabotulinumtoxinA |
| Placebo-Controlled Group | Placebo comparator | Single injection with placebo in glabellar lines Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.
The composite response rate: The proportion of participants achieving a score of 0 or 1 and a two-grade improvement from the baseline, on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown.
Glabellar lines at maximal frown is based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
Measured: The 4th week after treatment
At the 1st week, 8th week, and 12th week after treatment, the composite response rate on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown.
Measured: At the 1st week, 8th week, and 12th week after treatment
Secondary outcomes (9)
The response rate on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
The response rate: The proportion of participants achieving a score of 0 or 1 and a two-grade improvement of GL severity from the baseline at maximal frown.
Measured: At the 1st week, 4th week, 8th week, and 12th week after treatment
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment.
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
Measured: At the 1st week, 4th week, 8th week, and 12th week after treatment
the severity of GL at rest on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
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 the 1st week, 4th week, 8th week, and 12th week after treatment
The duration of GL treatment effect when the maximal frown severity score returned to baseline score.
Measured: Within 12 weeks
At the 1st week, 4th week, 8th week, and 12th week after treatment, the improvement rate of glabellar lines severity at maximal frown on the participant's self-assessment.
Participant self-assessment of 9 subscales: +4 (complete improvement), +3 (significant improvement), +2 (moderate improvement), +1 (slight improvement), 0 (no change), -1 (minor aggravation), -2 (medium aggravation), -3 (significant aggravation), and-4 (very significant aggravation).
Improvement rate is defined as the proportion of participants with + 2 (moderate improvement) or above.
Measured: At the 1st week, 4th week, 8th week, and 12th week after treatment
At the 1st week, 4th week, 8th week, and 12th week after treatment, the participant's satisfaction.
Satisfaction will be assessed on the 7-grade scale: 1 (very dissatisfied), 2 (dissatisfied), 3 (somewhat dissatisfied), 4 (reluctantly), 5 (relatively satisfied), 6 (satisfied) and 7 (very satisfied).
Calculate the proportion of participants with 6 or above.
Measured: At the 1st week, 4th week, 8th week, and 12th week after treatment
Incidence of adverse events and serious adverse events within 12 weeks of treatment.
Measured: Within 12 weeks of treatment
Incidence of injection site reactions within 12 weeks of treatment.
Measured: Within 12 weeks of treatment
Incidence of anti-drug antibodies and neutralizing antibodies within 12 weeks of treatment.
Measured: Within 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start28 Dec 2023
- Primary completion29 Mar 2024
- Study completion31 May 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo- and active-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 529 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
- NCT06499688
- Sponsor's protocol ID
- YY001-001-Ⅲ-REFINE
- Other IDs
- CTR20233901
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Active-controlled Parallel-group Multi-center Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06499688
- Acronym / sponsor ID
- YY001-001-Ⅲ-REFINE
- 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
- 529 participants (actual)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Jul 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 randomized, double-blind, placebo- and active-controlled parallel-group multi-center phase III study to evaluate the efficacy and safety of Rcombinant botulinum neurotoxin type A for injection (YY001)) in the treatment of moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo- and active-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: Rcombinant botulinum neurotoxin type A for injection (YY001)Single injection with Rcombinant botulinum neurotoxin type A for injection(YY001) in glabellar lines |
| Active-Controlled Group | Active comparator | Biological: OnabotulinumtoxinASingle injection with BOTOX® in glabellar lines |
| Placebo-Controlled Group | Placebo comparator | Biological: PlaceboSingle injection with placebo in glabellar lines |
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 and baseline, moderate to severe glabellar lines (grade of 2 or 3 on the 4-point Scale) at maximal frown as assessed by both the Investigator and the participant on-site.
- 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 administration of study drug or a urine pregnancy test examination must be negative 3 days prior to the administration of study drug.
Key exclusion criteria (14 listed)
- Known allergy to any component of the test product (includes investigational product and comparator product), or hypersensitivity.
- Previous cosmetic manipulation of the area between the eyebrows, within 12 months prior to screening; implantation of autologous fat or any permanent material; history of upper face lifting or semi-permanent prosthetic fillers, etc.; or plan to undergo upper face cosmetic manipulation during the study period (note: except for study drug injections);
- Use of any botulinum toxin within 6 months prior to baseline, or planned use of botulinum toxin during the study (note: except for use of investigational drugs at the study site).
- Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants (e.g., heparin, coumarins, non-vitamin K antagonists, oral anticoagulants within 1 week prior to baseline.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to baseline, including but not limited to: muscarinic agents, aminoglycosides, anticholinergic agents, benzodiazepines.
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)Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. | Biological | Treatment Group |
| OnabotulinumtoxinASingle treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. | Biological | Active-Controlled Group |
| PlaceboSingle treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site. | Biological | Placebo-Controlled Group |
Primary outcome
The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown.
Time frame: The 4th week after treatment
The composite response rate: The proportion of participants achieving a score of 0 or 1 and a two-grade improvement from the baseline, on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown. Glabellar lines at maximal frown is based on the 4 grade Facial Wrinkle Scale: 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
At the 1st week, 8th week, and 12th week after treatment, the composite response rate on both the investigator's assessment and the participant's self- assessment concurrently of GL severity at maximal frown.
Time frame: At the 1st week, 8th week, and 12th week after treatment
9 secondary outcomes
The response rate on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment and the participant's self-assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
the severity of GL at rest on the investigator's assessment and the participant's self- assessment individually of GL severity at maximal frown and the Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
The duration of GL treatment effect when the maximal frown severity score returned to baseline score.
Time frame: Within 12 weeks
At the 1st week, 4th week, 8th week, and 12th week after treatment, the improvement rate of glabellar lines severity at maximal frown on the participant's self-assessment.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
At the 1st week, 4th week, 8th week, and 12th week after treatment, the participant's satisfaction.
Time frame: At the 1st week, 4th week, 8th week, and 12th week after treatment
Incidence of adverse events and serious adverse events within 12 weeks of treatment.
Time frame: Within 12 weeks of treatment
Incidence of injection site reactions within 12 weeks of treatment.
Time frame: Within 12 weeks of treatment
Incidence of anti-drug antibodies and neutralizing antibodies within 12 weeks of treatment.
Time frame: Within 12 weeks of treatment
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 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Moderate to Severe Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
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) and OnabotulinumtoxinA 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 14 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 24 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
The 4th week after treatment, the composite response rate on both the investigator's assessment and the participant's self-assessment concurrently of GL severity at maximal frown. (time frame: The 4th week after treatment). The study lists 2 primary outcomes in all. 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 24 Jul 2024.