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 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT03014635
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent including authorization to release health information
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial
Exclusion Criteria:
* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03014635
Study Brief:
Protocol Section:
NCT03014635