Phase 3
Completed N=413
Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Glabellar Frown Lines (GL) · Lateral Canthal Lines (LCL)
Source: ClinicalTrials.gov NCT04247074 ↗
Enrolled (actual)
413
Serious AEs
0.7%
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown — 0; 75; 78 Participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown |
0; 75; 78 | <0.001 sig |
| PRIMARY Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile |
53; 0; 59 | <0.001 sig |
| SECONDARY Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown |
1; 97; 102 | <0.001 sig |
| SECONDARY Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. |
89; 10; 89 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female 18 years of age or older.
- Moderate to severe LCL at maximum smile as assessed by the Investigator.
- Moderate to severe LCL at maximum smile as assessed by the subject.
- Moderate to severe GL at maximum frown as assessed by the Investigator.
- Moderate to severe GL at maximum frown as assessed by the subject
Exclusion Criteria
- Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).
Data sourced from ClinicalTrials.gov (NCT04247074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.