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

NCT06499688 | Completed Phase 3 DMC

• 2 other identifiers: YY001-001-Ⅲ-REFINECTR20233901
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 16

Brief 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

Moderate to Severe Glabellar Lines

Keywords

YY001; Recombinant Botulinum Toxin Type A; Botulinum Toxin; Glabellar Lines

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  At the 1st week, 4th week, 8th week, and 12th week after treatment

Study Arms (3)

Treatment Group

EXPERIMENTAL

Single injection with Rcombinant botulinum neurotoxin type A for injection(YY001) in glabellar lines

Biological: Rcombinant botulinum neurotoxin type A for injection (YY001)

Active-Controlled Group

ACTIVE COMPARATOR

Single injection with BOTOX® in glabellar lines

Biological: OnabotulinumtoxinA

Placebo-Controlled Group

PLACEBO COMPARATOR

Single injection with placebo in glabellar lines

Biological: Placebo

Interventions

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.

Treatment Group

OnabotulinumtoxinA BIOLOGICAL

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

Active-Controlled Group

Placebo BIOLOGICAL

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

Placebo-Controlled Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Claruvis Pharmaceutical Co., Ltd.: lead

Study Sites (16)

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, Tan, China

Location

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xian, Shanxi, China

Location

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Peking Union Medical College Hospital , Chinese Academy of Medical Sciences

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Plastic Surgery Hospital, Chinese Academy of Medical Science

Beijing, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

MeSH Terms

Interventions

Injections; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yan Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo- and active-controlled

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: December 28, 2023
• Primary Completion: March 29, 2024
• Study Completion: May 31, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)