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A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection (Eveotox) Compared With a Single Treatment of Botox and Placebo,and Repeated Treatment of Eveotox in Moderate to Severe Glabellar Lines
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.
Details
| Lead sponsor | JHM BioPharma (Tonghua) Co. , Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 669 |
| Start date | 2025-04-30 |
| Completion | 2026-08 |
Conditions
- Moderate to Severe Glabellar Lines
Interventions
- Rcombinant botulinum toxin type A for injection（Eveotox)
- OnabotulinumtoxinA (Botox)
- Placebo
Primary outcomes
- 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.
Countries
China