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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT03915067
Eligibility Criteria:
Inclusion Criteria:
* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
* A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol
Exclusion Criteria:
* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of alcohol or drug abuse within 12 months of the study
* Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03915067
Study Brief:
Protocol Section:
NCT03915067