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Recombinant Botulinum Neurotoxin for Glabellar Lines

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Study Aim

This study aims to evaluate the effectiveness and safety of a new botulinum toxin treatment for reducing frown lines in adults.

What is being tested

YY003

+ Vehicle Control

Biological
Who is being recruted

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorChongqing Claruvis Pharmaceutical Co., Ltd.
Study ContactPan LinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 9, 2025

Actual date on which the first participant was enrolled.

This study aims to test a new treatment for people with moderate to severe glabellar lines, which are the vertical lines or wrinkles that can form between the eyebrows. The research involves 174 adult participants who will receive an injection of a medicine called YY003. The goal is to see if YY003 can safely and effectively reduce the appearance of these lines compared to a placebo. This study is important because it could offer a new option for individuals seeking to improve the appearance of their glabellar lines. Participants in this study will be randomly assigned to one of two groups. One group will receive the YY003 injection, while the other group will receive a placebo, which looks like the treatment but contains no active ingredients. The study is "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual treatment and who is receiving the placebo. This helps ensure that the results are unbiased. The study will monitor the safety and effectiveness of the treatment, as well as how the body responds to it, which is known as immunogenicity.

Official TitleA 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
Principal SponsorChongqing Claruvis Pharmaceutical Co., Ltd.
Study ContactPan LinMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

174 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
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.
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12 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive a single dose over 5 injection sites on Day 1.

Group II

Experimental
Participants will receive a single dose over 5 injection sites on Day 1.

Group III

Placebo
Participants will receive a single dose over 5 injection sites on Day 1.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

St George Dermatology & Skin Cancer Centre

Sydney, AustraliaOpen St George Dermatology & Skin Cancer Centre in Google Maps
Recruiting

Skin Health Institute

Melbourne, Australia
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Dermatology Institute of Victoria

Melbourne, Australia
Recruiting
3 Study Centers