YY003-001-US01 Enrolling

Research Trial for Glabellar/ Frown Lines (14-26 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults aged 18 years or older with glabellar/frown lines between the eyebrows, may be eligible to participate.

Inclusion Criteria:

      • Moderate to severe glabellar lines at maximum frown, as assessed by both investigator and participant, at Screening and Day 1

Participant Info:

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialise in treating glabellar lines
      • Will receive investigational injected treatment (active study drug) or placebo
      • Reimbursement for study visits will be provided

How Long Will The Study Last?

      • Participants in Part A will be in the study for up to 26 weeks (about 10 visits) and those in Part B will be in the study for up to 14 weeks (about 6 visits)

Participating Locations

COUNTRY
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Australia

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: December 11, 2024

Official 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

ClinicalTrials.gov ID

NCT06481475

Sponsor

Chongqing Claruvis Pharmaceutical Co., Ltd.

Study Description

  • Brief 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 vehicle control, in improving the appearance of moderate to severe glabellar lines.

  • Condition or Disease:

    Moderate to Severe Glabellar Lines

  • Intervention/Treatment:

    Biological: YY003 Biological: YY003 Biological: Vehicle Control
  • Phase:

    PHASE 2

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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Glabellar Lines

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