Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Recruiting
Phase 3
Interventional Study
Moderate to Severe Glabellar Lines
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 669 (estimated)
- Sponsor
- JHM BioPharma (Tonghua) Co. , Ltd. · Research network
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About This Trial
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-controlle…
Trial Locations
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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…
Contacts