drugset / Trial / NCT05463965
A Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a phase 3, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate the efficacy and safety of 50 units (U) of QM1114-DP for the treatment of moderate to severe GL in male and female subjects of Chinese origin. The study has been designed to test the superiority of QM1114-DP compared to placebo, and the non-inferior efficacy of QM1114-DP compared to onabotulinumtoxinA (BOTOX®), in improving the appearance of moderate to severe GL.
Timeline
- Start
- 2022-07-29
- Primary completion
- 2023-01-29
- Completion
- 2023-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin | Protein / enzyme biologic | 50 iu | Intramuscular |
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | — | Intramuscular |
Indications
No indication recorded.