Methods |
Randomised, double‐blind, placebo‐controlled, multicentre trial |
Participants |
300 participants 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 participant
Exclusion Criteria
Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment
Female who is pregnant, breastfeeding, 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
Country USA |
Interventions |
Intervention
Comparator
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Outcomes |
Primary outcome
Secondary outcome
Percentage of participants with a 0 or 1 on the Glabellar Lines Investigator scale at maximum frown [Frame: Baseline through Month 6]
Number of participants who experienced an adverse event [Time Frame: Baseline through Month 6]
Number of participants with abnormal post‐baseline QTcF and QTcB intervals [Time Frame: Baseline through Month 6]
Number of participants with binding neutralising antibodies [Time Frame: Baseline through Month 6]
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Notes |
Q‐Med AB |