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

NCT06585696 | Completed Phase 3

• 1 other identifier: CU-20101-305
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CU-20101

Outcome Measures

Primary Outcomes (1)

• • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection.

  • Proportion of subjects with an FWS score of 0 or 1 and both with a decrease of ≥ 2 points from baseline as assessed on-site by the investigator and the subject at Week 4 after the first round of injection.

  Stage 1: Screening period of 7 days, treatment + follow-up about 12 weeks, the longest 92 days; Stage 2: Treatment + follow-up for about 36 weeks. All together takes up to 344 days

Study Arms (2)

Botox®

ACTIVE COMPARATOR

Botox® treatment for Moderate to Severe Glabellar Striae

Drug: BOTOX®

CU-20101

EXPERIMENTAL

CU-20101 treatment for Moderate to Severe Glabellar Striae

Drug: CU-20101 treatment for Moderate to Severe Glabellar Striae

Interventions

BOTOX® DRUG

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.

Botox®

CU-20101 treatment for Moderate to Severe Glabellar Striae DRUG

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.

CU-20101

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• After being fully informed, fully aware of the content, process, benefits and possible adverse reactions of the study, and voluntarily participate in the study, and sign the informed consent form;
• Men or women aged 18-65 years (including boundary values);
• At screening, the investigator assessed the severity of glabellar lines when the subject tried to frown based on a 4-point FWS, with a score of ≥ 2 points;
• Subjects self-assessed the severity of glabellar lines when trying to frown based on a 4-point FWS score ≥ 2 points;
• Subjects were able to communicate well with the investigator and were willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• Subjects with skin abnormalities, including active infections (e.g., herpes simplex, acne, etc.), skin diseases (e.g., psoriasis, eczema, etc.), scars, etc., which may interfere with the study assessment as judged by the investigator;
• Subjects with diseases that may affect neuromuscular function (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.); or previous history of epilepsy;
• Previous history of facial paralysis and ptosis;
• Significant facial asymmetry;
• Physical stretching methods (e.g., manual stroking of equality) do not reduce eyebrow lines;
• Subjects allergic to the investigational product and its excipients (e.g., botulinum toxin, serum albumin, etc.);
• Subjects with prior surgery on the upper face (e.g. eyebrow lifting surgery), autologous fat implantation, semi-permanent or permanent material injection filling or implantation;
• Subjects who have received botulinum toxin injection of any serum type within 6 months prior to screening;
• Subjects who have received degradable fillers such as hyaluronic acid, collagen, etc. in the upper facial region within 12 months prior to screening;
• Subjects who have received intense pulsed light (photon), chemical denudation, etc., within 3 months prior to screening; for partial radiofrequency or high-energy laser treatment, the investigator should extend the interval to 6 months or more according to the actual situation;
• Subjects who plan to receive other medical aesthetic treatments (e.g., laser, injection tamponade, chemical peeling, etc.) or any treatment that may result in significant weight change (e.g. liposuction surgery, oral weight loss drugs, etc.) or who are expected to require treatment with botulinum toxin of any serum type (other than study intervention) during the study;
• Subjects taking oral retinoids within 6 months prior to screening or topical retinoids on the face within 3 months prior to screening;
• Subjects who have used the following systemic drugs within 1 month prior to screening: drugs with muscle relaxant effects (e.g., tubocurarine chloride, dantrolene sodium, baclofen, etc.), aminoglycoside antibiotics (e.g., gentamicin sulfate, neomycin sulfate, etc.), polypeptide antibiotics (e.g., polymyxin B sulfate), tetracycline antibiotics, lincolamides, anticholinergic drugs (e.g., hyoscine butylbromide hydrochloride, benzhexol hydrochloride, etc.), benzodiazepines (e.g., etizolam, etc.), benzamide drugs (e.g., thiopride hydrochloride, sulpiride, etc.);
• Subjects who have used anticoagulants or non-steroidal anti-inflammatory drugs within 7 days prior to study drug administration; for menstruating subjects, the study drug injection may be delayed as needed to avoid the menstrual period;
• Pregnant or lactating women;

Sponsors & Collaborators

• Cutia Therapeutics（Wuxi）Co.,Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 200443, China

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Yan Wu, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel +Single Group

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: June 24, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)