Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT06151561
Eligibility Criteria:
Inclusion Criteria:
* Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
* Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.
Exclusion Criteria:
* Participants must not have uncontrolled systemic disease.
* History of known immunization to any botulinum neurotoxin serotype
* Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed.
* Anticipated need for surgery or overnight hospitalization during the study.
* History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
* History of periorbital, mid-facial, or upper-facial treatment with semi permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
* Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
* Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer.
* Participant who has been treated with any investigational drug within 30 days of the drug prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
* Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT06151561
Study Brief:
Protocol Section:
NCT06151561