Skip to main content
OpenTrials
Completed

NCT Number: NCT06481475

A Study to Investigate the Safety and Efficacy of YY003 in Adults With Moderate to Severe Glabellar Lines

The study is a two-part (Part A and Part B) randomized double-blind vehicle-controlled multi-center study in a total of 174 participants with moderate to severe glabellar lines. The objective of this study is to test the safety, efficacy, immunogenicity of YY003, and compare to vehicel control, in improving the appearance of moderate to severe glabellar lines.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St George Dermatology & Skin Cancer Centre, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
  • At screening and baseline, participants must have moderate to severe glabellar lines at maximum frown (grade 2 or 3 on the relevant 4-point scale), as assessed by both the investigator and the participant.
  • Male or female (inclusive of all gender identities) participants are eligible to participate if they agree to practice adequate contraceptive methods during the study period and for at least 3 months after the study drug administration. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.

Exclusion criteria

  • Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
  • A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
  • A history or presence of facial nerve palsy at screening or baseline.
  • A positive HIV, hepatitis B or hepatitis C test at screening.
  • History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
  • History of drug or alcohol abuse.
  • History or presence of epilepsy.
  • Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.
  • Female who is pregnant or breast feeding.
  • Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study.
  • Participation in an investigational device or drug study within 30 days or 5 half-lives (whichever is longer) prior to screening.
  • Study center personnel, close relatives of the study center personnel, employees or close relatives of employees at the sponsor company.

Treatment and study plan

YY003

Biological

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

Vehicle Control

Biological

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

Primary outcomes

  1. Satety: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESI), and serious adverse events (SAEs)

    Time frame: within 4 weeks post-treatment

  2. Efficacy: The proportion of participants achieving a score of 0 or 1 and at least a two-grade improvement from baseline, on both the investigator's assessment and the participant's self-assessmenti of glabellar line severity at maximum frown

    Time frame: at Week 4 post-treatment visit

Secondary outcomes

  1. Incidence of anti-drug antibodies and neutralizing antibodies

    Time frame: Within 12 Weeks

Sponsors and collaborators

Lead sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized Double-blind Vehicle-controlled Parallel-dose Phase II Study Evaluating the Safety and Efficacy of a Recombinant Botulinum Neurotoxin Type A Injection (YY003) for the Treatment of Moderate to Severe Glabellar Lines in Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.