NCT04249583CompletedPhase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 300
- Locations
- 14
- Primary Endpoint
- Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Placebo
Placebo Comparator
A buffered solution; Mode of administration: intramuscular injection
Intervention: Placebo (Biological)
Treatment
Experimental
QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
Intervention: botulinum toxin (Biological)
Outcomes
Primary Outcomes
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
Time Frame: One Month
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
Secondary Outcomes
- Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown(One Month)
Investigators
Study Sites (14)
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