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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 529

Last updated 2024-07-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

Rcombinant botulinum neurotoxin type A for injection (YY001)

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

BIOLOGICAL

OnabotulinumtoxinA

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Chongqing Claruvis Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Wu · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2024-03-29
Completion
2024-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06499688 on ClinicalTrials.gov