Phase 3
N=902
Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Glabellar Lines · Lateral Canthal Lines
Bottom Line
View on ClinicalTrials.gov: NCT04225260 ↗Enrolled (actual)
902
Serious AEs
2.6%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown — 769 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin neuromodulator (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown |
769 | — |
| PRIMARY Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile |
719 | — |
Summary
This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).
Eligibility Criteria
Inclusion Criteria
- Male or female at least 18 years of age.
Exclusion Criteria
- Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
- 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) or any botulinum toxin serotype.
Data sourced from ClinicalTrials.gov (NCT04225260). 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.