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Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines

NCT06937944

RecruitingPhase 3

Sponsor: JHM BioPharma (Tonghua) Co. , Ltd.

Conditions: Moderate to Severe Glabellar Lines

Interventions: Rcombinant botulinum toxin type A for injection（Eveotox), OnabotulinumtoxinA (Botox), Placebo

Countries: China

This is a Phase 3 clinical study to evaluate the efficacy, safety, and immunogenicity of single/repeated injections of Eveotox in the treatment of moderate to severe glabellar lines. The study consists of Study Part 1 (randomized double-blind controlled study) and Part 2 (open-label study). Part I is a multicenter, randomized, double-blind, single-injection, active-controlled and placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of Eveotox in the treatment of moderate to severe glabellar lines; Part 2 is an open-label study to evaluate the efficacy, safety, and immunogenicity of repeated injections of Eveotox in the treatment of moderate to severe glabellar lines.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female subjects who are between 18 to 65 years of age
* Moderate or severe glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity scale
* Moderate or severe glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Subjects who have a history of oversensitivity to the Botulinum Toxin A type or other components of the study drug
* Subjects who have implanted any permanent materials in the glabellar area or received semi-permanent fillers within the first 2 years of screening
* Subjects with active skin infections at the injection site or systemic skin disease, which the investigator judges can affect the evaluation of efficacy or safety
* Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period

Locations (15)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Changsha, Hunan, China
Xuzhou, Jiangsu, China
Shanghai, Shanghai Municipality, China
Xianyang, Shanxi, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China