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RECRUITINGPHASE2

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

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

NCT06481475•Chongqing Claruvis Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants (male or female) must be ≥18 years old, at the time of signing the informed consent.
•2. 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.
•3. 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.
•4. Participant must provide signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•5. Participant must have the time and ability to complete the study and comply with instructions, at the discretion of the investigator.

Exclusion Criteria

•1. Known allergy or hypersensitivity to any components of the investigational product or any botulinum toxin serotype.
•2. A history or presence of ptosis, significant facial asymmetry, excessive dermatochalasis at screening or baseline.
•3. A history or presence of facial nerve palsy at screening or baseline.
•4. A positive HIV, hepatitis B or hepatitis C test at screening.
•5. History or presence of other concomitant diseases which are assessed by the investigator to be unsuitable for participation in this clinical research.
•6. History of drug or alcohol abuse.
•7. History or presence of epilepsy.
•8. Have a serious mental disorder that, in the Investigator's opinion, may affect participant compliance with the study.
•9. Female who is pregnant or breast feeding.
•10. Abnormal laboratory tests that, in the Investigator's assessment, are not appropriate for participation in this study.
+2 more criteria

Locations (3)

St George Dermatology & Skin Cancer Centre

Sydney, New South Wales, Australia

Skin Health Institute

Melbourne, Victoria, Australia

Dermatology Institute of Victoria

Melbourne, Victoria, Australia

Key Dates

Start Date

January 9, 2025

Primary Completion Date

July 1, 2025

Completion Date

October 1, 2025

Last Updated

March 21, 2025

Enrollment

174

ESTIMATED participants

Conditions

Moderate to Severe Glabellar Lines

Interventions

YY003

BIOLOGICAL

Vehicle Control

BIOLOGICAL

Contacts

Pan Lin

CONTACT

+86 18183052779 pan.lin@claruvis.com

Sun Xiaoyun

CONTACT

+86 13810399273 sun.xiaoyun@claruvis.com

A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

NCT06583486

Moderate to Severe Glabellar Lines

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Moderate to Severe Glabellar Lines

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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