Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
- Conditions
- Moderate to Severe Glabellar Lines
- Interventions
- Biological: Rcombinant botulinum toxin type A for injection（Eveotox)Biological: OnabotulinumtoxinA (Botox)Biological: Placebo
- Registration Number
- NCT06937944
- Lead Sponsor
- JHM BioPharma (Tonghua) Co. , Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 669
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eveotox Rcombinant botulinum toxin type A for injection（Eveotox) Eveotox, 20 Units, divided into five injections into the glabellar area. Administered in double-blind fashion at cycle 1 followed by up to 3 open-label cycles. OnabotulinumtoxinA (Botox ) OnabotulinumtoxinA (Botox) Botox,20 Units, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units). Placebo Placebo Placebo, will be administered in double-blind fashion during treatment cycle 1 only, followed by up to 3 of Eveotox(20 Units)
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measure Within 52 weeks Incidence of serious adverse events and drug-related adverse events during the study.
Trial Locations
- Locations (15)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Scroll for more (5 remaining)Peking Union Medical College Hospital🇨🇳Beijing, Beijing, China