A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Inject… (NCT06585696) | Clinical Trial Compass
CompletedPhase 3
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection (CU-20101)
China554 participantsStarted 2024-06-11
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
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.
Timeframe: 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
✕. 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;