NCT04225260CompletedPhase 3
A Multicenter, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 902
- Locations
- 60
- Primary Endpoint
- Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
Time Frame: Week 4
4-point scale
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
Time Frame: Week 4
4-point scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (60)
Loading locations...
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