NCT03985982.

Methods	Randomised, double‐blind, placebo‐controlled trial
Participants	353 participants Inclusion criteria Ages ≥ 18 years or older at time of screening Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as determined by in‐clinic assessments by both the investigator and the participant (where: 0 =´none´, 1= ´mild´, 2= ´moderate´, 3= ´severe´). Exclusion criteria Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton‐Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to screening, or any planned treatment with botulinum toxin of any serotype for any reason during the trail (other than the investigational treatment) Active skin disease/infection or irritation at the treatment area Pregnant, breastfeeding or planning to become pregnant during the trial Country: USA
Interventions	Intervention OnabotulinumtoxinA ‐injection, 20 U, divided in five 0.1 mL i.m injections into the glabellar area Comparator Placebo ‐divided in five 0.1 mL I.M.injections into the glabellar area
Outcomes	Primary outcome Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at wee= 4 visit relative to baseline, based on both the investigators´and the participants' in‐clinic assessments. [Time Frame: week 4 relative to baseline] Secondary outcomes Percentage of responders at maximum frown at week 12 [Time Frame: week 12] Percentage of responders at week 16 [Time Frame: week 16] The proportion of participants with a ≥ 1 point reduction in FWS score at rest at week 4 based separately on the investigators´and the participants' in‐clinic assessments [Time Frame: week 4] Percentage of responders at week 20 or up to week 48 [Time Frame: week 20] Frequency, severity and causal relationship of AEs, SAes and AESIs [Time Frame: through study completion [60 weeks]
Notes	Croma‐Pharma GmbH