Moderate to Severe Glabellar LinesPhase 1/2NCT05743634
A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines
A Phase 1/2 study testing YY001 and OnabotulinumtoxinA in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. 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?
- YY001 and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 6 sitesChina
- Study dates
- 22 Mar 2022to 13 Feb 2023
- Phase
- Phase 1/2
- 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 subjects from ≥18 to ≤65 years of age when signing an informed consent.
- At screening and baseline,the subject has moderate to severe GL (grade of 2 or 3 on the 4-point Scale) at maximum frown when assessed by both the Investigator and the subject.
- Agree to take part in the clinic trial and sign the informed consent form voluntarily.
- Is able to observe the protocol by Investigator's assessment.
- Male and female of childbearing potential agree to use a highly effective contraceptive method for the duration of the study(such as tubal ligation,abstinence,Intrauterine device,hormone,barrier method).For female of childbearing potential,her blood pregnancy test is negative within 7 days prior to study treatment,and urine pregnancy test is negative within 3 days prior to study treatment.Male can't donate the sperm within 3 months after treatment.
Who cannot join
- Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).
- Previous use of any cosmetic therapy in the glabella or forehead area,such as hyaluronic acid,phototherapy,hydrating needle,microneedle,chemical peeling,scar removal surgery or skin dermabrasion within 6 months before screening.Previous use of biodegradable filler within 12 months before screening,such as collagen,polylactic acid or calcium hydroxyapatite.Previous use of autologous fat, any permanent products (such as silicone, polyacrylamide,no matter how long the interval is) ,face-lift,or semi-permanent prosthesis.Planned use of any cosmetic therapy in the glabella or forehead area during the study(other than the study products).
- Previous use of any botulinum toxin within 6 months prior to screening,or plan to use any botulinum toxin during the study(other than the study products).
- Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
- Probably use of prohibited drug during the study,as assessed by the investigator.
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- Abnormal skin at in the treatment area,scar or physical scars, in the investigator's opinion,may interfere with study evaluations.
- Inability to substantially spread glabellar lines apart by surgery or finger smoothing, as determined by the investigator.
- Ptosis,excessive facial asymmetry and skin laxity ,at screening and baseline.
- History of facial nerve palsy.
- Any medical condition that may interfere neuromuscular function including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, dysphagia,dyspnea,diplopia,angle-closure glaucoma,eyelid or eyebrow ptosis,etc.
- Any concomitant disease including,unfit for the study by the investigator.
- In acute attack.
- Abnormal lab findings,and unfit for the study in the opinion of the investigator.
- History of alcohol or drug abuse.
- History of epilepsy.
- Any severe psychiatric illness ,in the investigator's opinion, could affect the subject's participation in the study.
- Female who is pregnant,or breast feeding.
- In any other clinical study ,or Participated in any other interventional study within 30 days or 5 half-lives prior to screening.
- Contract research organization,study site personnel or close relatives of the study site personnel , employees or close relatives of employees at the sponsor company.
- Other conditions, in the Investigator's opinion, unfit for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality
West China Hospital,Sichuan University
Chengdu, Sichuan
The First affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong
Shanghai Ninth People's Hospital,Shanghai JiaoTong University school of Medicine
Shanghai, Shanghai Municipality
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines
This is a phase 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance of moderate to severe glabellar lines.
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- YY001, OnabotulinumtoxinA, Placebo
- Keywords
- YY001, Botulinum Toxin, Glabellar Lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY001Biological
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 YY001 in glabellar lines Receives: Biological: 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.
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection
Measured: Within 28 days
Phase1:The incidence rate of injection site reaction within 28 days after injection
Measured: Within 28 days
Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection
Measured: Within 28 days
Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown
A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment
Measured: 28 days
Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection
Measured: within 12 weeks
Phase2:The incidence rate of injection site reaction within 12 weeks after injection
Measured: within 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start22 Mar 2022
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
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 1/2
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingfeng Li, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743634
- Sponsor's protocol ID
- YY001-001
- Other IDs
- CTR20221419
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 24 Feb 2023
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II,Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Safety,Efficacy and Immunogenicity of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05743634
- Acronym / sponsor ID
- YY001-001
- Conditions
- Moderate to Severe Glabellar Lines
- Keywords
- YY001, Botulinum Toxin, Glabellar Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chongqing Claruvis Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 24 Feb 2023 (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 1/2, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate safety,immunogenicity and efficacy of YY001 for the treatment of moderate to severe glabellar lines in male and female subjects of Chinese origin. The study has been designed to test the safety,efficacy,immunogenicity of YY001,and compare to onabotulinumtoxinA (BOTOX®) and placebo, in improving the appearance 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: YY001Single injection with 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 (5 listed)
- Male or female subjects from ≥18 to ≤65 years of age when signing an informed consent.
- At screening and baseline,the subject has moderate to severe GL (grade of 2 or 3 on the 4-point Scale) at maximum frown when assessed by both the Investigator and the subject.
- Agree to take part in the clinic trial and sign the informed consent form voluntarily.
- Is able to observe the protocol by Investigator's assessment.
- Male and female of childbearing potential agree to use a highly effective contraceptive method for the duration of the study(such as tubal ligation,abstinence,Intrauterine device,hormone,barrier method).For female of childbearing potential,her blood pregnancy test is negative within 7 days prior to study treatment,and urine pregnancy test is negative within 3 days prior to study treatment.Male can't donate the sperm within 3 months after treatment.
Key exclusion criteria (21 listed)
- Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).
- Previous use of any cosmetic therapy in the glabella or forehead area,such as hyaluronic acid,phototherapy,hydrating needle,microneedle,chemical peeling,scar removal surgery or skin dermabrasion within 6 months before screening.Previous use of biodegradable filler within 12 months before screening,such as collagen,polylactic acid or calcium hydroxyapatite.Previous use of autologous fat, any permanent products (such as silicone, polyacrylamide,no matter how long the interval is) ,face-lift,or semi-permanent prosthesis.Planned use of any cosmetic therapy in the glabella or forehead area during the study(other than the study products).
- Previous use of any botulinum toxin within 6 months prior to screening,or plan to use any botulinum toxin during the study(other than the study products).
- Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
- Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
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 |
|---|---|---|
| YY001Single 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
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection
Time frame: Within 28 days
Phase1:The incidence rate of injection site reaction within 28 days after injection
Time frame: Within 28 days
Phase1:The incidence rate of abnormal lab findings which have clinical significance within 28 days after injection
Time frame: Within 28 days
Phase2:The response rate will be evaluated at 28 days by investigator at maximum frown
Time frame: 28 days
A response rate is defined as a subject who achieves a score of 0 or 1 in GL severity at maximum frown and at least 2 grades improvement from baseline by investigator's assessment
Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection
Time frame: within 12 weeks
Phase2:The incidence rate of injection site reaction within 12 weeks after injection
Time frame: within 12 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 24 Feb 2023.
- 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.
Qingfeng Li principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YY001 and OnabotulinumtoxinA in people with Moderate to Severe Glabellar Lines, run by Chongqing Claruvis Pharmaceutical Co., Ltd. at 6 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 5 inclusion and 21 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection (time frame: Within 28 days). The study lists 6 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 Feb 2023.