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

NCT06937944 · tracked via the Priya Life Science China tracker

Sponsor

JHM BioPharma (Tonghua) Co. , Ltd.

Phase

Phase 3

Started

2025-04-30

Last updated

2026-09-23

Condition(s) studied

Moderate to Severe Glabellar Lines

Investigational drug(s) / intervention(s)

Rcombinant botulinum toxin type A for injection（Eveotox)OnabotulinumtoxinA (Botox) →Placebo

Rcombinant botulinum toxin type A for injection（Eveotox): Rcombinant botulinum toxin type A for injection（Eveotox)

OnabotulinumtoxinA (Botox): OnabotulinumtoxinA (Botox)

Placebo: Placebo

Study summary

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Primary Outcome Measure — Within 4 weeks
Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit relative to baseline, based on both the investigators´ and the subjects´ in-clinic assessments.

Trial sites (15)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	Beijing Municipality	Recruiting
Peking University First Hospital	Beijing	Beijing Municipality	Recruiting
Peking University Third Hospital	Beijing	Beijing Municipality	Recruiting
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting
The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong	Recruiting
The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting
The First Hospital of Hebei Medical University	Shijiazhuang	Hebei	Recruiting
The Third Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	Recruiting
Huashan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting
Xianyang Hospital of Yan'an University	Xianyang	Shanxi	Recruiting
West China Hospital, Sichuan University	Chengdu	Sichuan	Recruiting
Tianjin Medical University General Hospital	Tianjin	Tianjin Municipality	Recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University	Hangzhou	Zhejiang	Recruiting
Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	Recruiting

More JHM BioPharma (Tonghua) Co. , Ltd. trials in China

Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection in the Treatment of Adult Upper Limb Spasticity . Recruiting

Other trials for the same condition

A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937944 on ClinicalTrials.gov ↗ ← All trials in China