Phase 3
N=300
Treatment of Moderate to Severe Glabellar Lines
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT04249583 ↗Enrolled (actual)
300
Serious AEs
2.0%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month. — 165; 0 Participants — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Aug 2020
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 at One Month. |
165; 0 | 0.05 |
| SECONDARY Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown |
187; 3 | — |
Summary
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.
Eligibility Criteria
Inclusion Criteria
- Male or female 18 years of age 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.
- Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.
Data sourced from ClinicalTrials.gov (NCT04249583). 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.