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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01309802
Eligibility Criteria:
Inclusion Criteria:
* aged 18-75 years
* diagnosed with Raynaud's disease/phenomenon
* ischemia not due to peripheral artery disease or other vascular disease
* otherwise healthy individual
* up-to-date tetanus immunization
* ability to return/be available for follow-up evaluations
* ability/willingness to give informed consent
Exclusion Criteria:
* HIV/AIDS positive or otherwise immunocompromised
* history of neuromuscular disease
* reported allergy to BOTOX®; reported allergy to lidocaine or other local anesthetic agent
* ever received botulinum toxin vaccine
* ultrasound or angiogram showing digital ischemia due to blocked vessel and not Raynaud's disease
* history or symptoms of any significant medical problem in the last year (i.e., bradycardia, impaired cardiovascular function, liver disease)
* symptoms of infection or illness during initial enrollment
* pregnant or lactating women
* unable or unwilling to maintain abstinence or use contraception for 28 days following all injections
* cognitive impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01309802
Study Brief:
Protocol Section:
NCT01309802