A Phase I/II Study of Recombinant Botulinum Toxin Type A for the Treatment of Moderate to Severe Glabellar Lines

February 15, 2023 updated by: Chongqing Claruvis Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital，Southern Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai ninth People's Hospital,Shanghai Jiaotong University School of Medicine
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital,Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects from ≥18 to ≤65 years of age when signing an informed consent.
  2. 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.
  3. Agree to take part in the clinic trial and sign the informed consent form voluntarily.
  4. Is able to observe the protocol by Investigator's assessment.
  5. 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.

Exclusion Criteria:

  1. Known allergy or hypersensitivity to any component of the study products(YY001 or BOTOX®).
  2. 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).
  3. 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).
  4. Use of any non-steroid anti-inflammatory drug or anticoagulant within 1 week prior to study treatment.
  5. Use of medications that affect neuromuscular transmission within 4 weeks prior to screening, such as muscle relaxant,aminoglycoside antibiotics,anticholinergic drugs,benzodiazepines,etc.
  6. Probably use of prohibited drug during the study,as assessed by the investigator.
  7. Abnormal skin at in the treatment area,scar or physical scars, in the investigator's opinion,may interfere with study evaluations.
  8. Inability to substantially spread glabellar lines apart by surgery or finger smoothing, as determined by the investigator.
  9. Ptosis,excessive facial asymmetry and skin laxity ,at screening and baseline.
  10. History of facial nerve palsy.
  11. 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.
  12. Any concomitant disease including,unfit for the study by the investigator.
  13. In acute attack.
  14. Abnormal lab findings,and unfit for the study in the opinion of the investigator.
  15. History of alcohol or drug abuse.
  16. History of epilepsy.
  17. Any severe psychiatric illness ,in the investigator's opinion, could affect the subject's participation in the study.
  18. Female who is pregnant,or breast feeding.
  19. In any other clinical study ,or Participated in any other interventional study within 30 days or 5 half-lives prior to screening.
  20. Contract research organization,study site personnel or close relatives of the study site personnel , employees or close relatives of employees at the sponsor company.
  21. Other conditions, in the Investigator's opinion, unfit for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active-Controlled Group
Single injection with BOTOX® in glabellar lines
Biological: OnabotulinumtoxinA
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Placebo Comparator: Placebo-Controlled Group
Single injection with placebo in glabellar lines
Biological: Placebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
Experimental: Treatment Group
Single injection with YY001 in glabellar lines
Biological: YY001
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase1:The incidence rate of adverse events and severe adverse events within 28 days after injection
Time Frame: Within 28 days
Within 28 days
Phase1:The incidence rate of injection site reaction within 28 days after injection
Time Frame: Within 28 days
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
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
28 days
Phase2:The incidence rate of adverse events and severe adverse events within 12 weeks after injection
Time Frame: within 12 weeks
within 12 weeks
Phase2:The incidence rate of injection site reaction within 12 weeks after injection
Time Frame: within 12 weeks
within 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chongqing Claruvis Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qingfeng Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YY001-001
  • CTR20221419 (Registry Identifier: www.chinadrugtrials.org.cn)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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