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. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

NCT04249583.

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
  • QM1114‐DP‐ intramuscular injection into glabellar lines


Comparator
  • Placebo‐ intramuscular injection into glabella lines

Outcomes Primary outcome
  • Percentage of participants with a ≥ 2‐grade improvement from baseline on the Glabellar Lines Investigator and participant assessments at maximum frown at one month. [Time Frame: One Month]


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]

Notes Q‐Med AB