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:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT02108158
Eligibility Criteria:
Key Inclusion Criteria:
* Women, 18 to 64 years of age
* Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.
Key Exclusion Criteria:
* Subjects previously treated with any botulinum toxin product.
* Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
* Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
* Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.
* Subjects with previous or current diagnosis of Bell's paresis.
* Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
* Subjects who are taking anticholinergics or aminoglycoside antibiotics.
* Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
* Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02108158
Study Brief:
Protocol Section:
NCT02108158