Phase 3
N=132
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT05146999 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 — 92; 3 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- QM1114-DP (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1 |
92; 3 | <0.001 sig |
| SECONDARY Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card |
89; 3 | — |
| SECONDARY Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12 |
39; 4; 66; 4; 79; 4 | — |
Summary
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
Eligibility Criteria
Inclusion Criteria
- Male or Female 18 years or older
- 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.
Data sourced from ClinicalTrials.gov (NCT05146999). 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.