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A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)

NCT06585696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2026-06-15

No results posted yet for this study

Summary

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines. The study consisted of a 7-day screening period, Study Part 1 (randomized double-blind controlled study) and Period 2 (open-label study). Part I was a multicenter, randomized, double-blind, single-injection, active-drug parallel-controlled, non-inferiority design clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20101 in the treatment of moderate to severe glabellar stria compared with a single injection of Botox®; part 2 was an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of CU-20101 in the treatment of moderate to severe glabellar lines.

Conditions

  • Glabellar Frown Lines

Interventions

DRUG

CU-20101 treatment for Moderate to Severe Glabellar Striae

Drug: CU-20101 treatment for Moderate to Severe Glabellar Striae Part I comprised a single-day baseline and treatment phase, in which subjects were randomized to receive one dose of investigational product, followed by a 12-week post-treatment follow-up period.For Arm "CU-20101", the arm should recept "CU-20101" assigned to it. All subjects who completed Part I will progressed into Part II. This open-label phase aimed to assess the safety, efficacy and immunogenicity of repeated CU-20101 injections for moderate-to-severe glabellar frown lines. Re-treatment was permitted only when predefined retreatment criteria were satisfied, with a minimum 12-week interval between consecutive investigational product injections. If retreatment criteria were not fulfilled at a scheduled follow-up visit, subjects would continue follow-up assessments at 4-week intervals until eligibility for repeat injection was met. The final study treatment was administered no later than Day 253 ±7 days.

DRUG

BOTOX®

Drug: Botox® treatment for Moderate to Severe Glabellar Striae Part I comprised a single-day baseline and treatment phase, in which subjects were randomized to receive one dose of investigational product, followed by a 12-week post-treatment follow-up period. For Arm "Botox®", the arm should receipt "Botox®" assigned to it.

Sponsors & Collaborators

  • Cutia Therapeutics（Wuxi）Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yan Wu, PhD · 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
2024-06-24
Primary Completion
2025-11-20
Completion
2025-11-20

Countries

  • China

Study Locations

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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 NCT06585696 on ClinicalTrials.gov