CompletedNCT06499688Updated Jul 24, 2024

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 interventional study of Rcombinant botulinum neurotoxin type A for injection (YY001) and OnabotulinumtoxinA in Moderate to Severe Glabellar Lines, sponsored by Chongqing Claruvis Pharmaceutical Co., Ltd.. Completed at 16 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-24.

Sponsored by Chongqing Claruvis Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Dec 2023, registered Jul 2024).

Phase: Phase 3
Study type: Interventional
Enrollment: 529
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Moderate to Severe Glabellar Lines

Keywords

YY001
Recombinant Botulinum Toxin Type A
Botulinum Toxin
Glabellar Lines

In context

Lead sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 529 participants (actual)

Study arms

Experimental
Treatment Group
Single injection with Rcombinant botulinum neurotoxin type A for injection(YY001) in glabellar lines
Biological: Rcombinant botulinum neurotoxin type A for injection (YY001)
Active comparator
Active-Controlled Group
Single injection with BOTOX® in glabellar lines
Biological: OnabotulinumtoxinA
Placebo comparator
Placebo-Controlled Group
Single injection with placebo in glabellar lines
Biological: Placebo

Interventions

BiologicalRcombinant 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.
BiologicalOnabotulinumtoxinA
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.
BiologicalPlacebo
Single treatment,intramuscularly injected into five sites.The total injection volume is 0.25 ml,0.05 ml per site.

What researchers measure

Primary outcomes

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).
Time frame: 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.
Time frame: At the 1st week, 8th week, and 12th week after treatment

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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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

Study locations

16 sites

Guangdong Second People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan Tan, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xian, Shanxi, China
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Beijing Tsinghua Changgung Hospital
Beijing, China
Peking Union Medical College Hospital , Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Plastic Surgery Hospital, Chinese Academy of Medical Science
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Tianjin Medical University General Hospital
Tianjin, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Mar 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 7, 2024
First posted: Jul 12, 2024
StartActual: Dec 28, 2023
Primary completionActual: Mar 29, 2024
CompletionActual: May 31, 2024
Last update: Jul 24, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06499688
Lead sponsor: Chongqing Claruvis Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jul 12, 2024
Start date: Dec 28, 2023
Primary completion: Mar 29, 2024
Completion: May 31, 2024
Last update: Jul 24, 2024

Study contacts

Yan Wu

principal investigator · Peking University First Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: EP4 Receptor Antagonist YY001

Other studies from this sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

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