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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT03717961
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and older
* Diagnosed with systemic sclerosis (EULAR/ACR 2013 criteria ; or Leroy and Metsger criteria).
* Symptoms of Raynaud's phenomenon affecting both hands (not necessarily to equal extents)
* Frequency of Raynaud's attacks ≥ 5/week during cold weather
* Stable dose of phosphodiesterase inhibitors (sildenafil, tadalafil or vardenafil), endothelin antagonists, or calcium channel blockers defined as 1-month with no change in dose
* Ability to return/be available for follow-up evaluations
* Ability to fill the diary
* Ability/willingness to give informed consent
* Affiliation to any French social security regime
Exclusion Criteria:
* History of myasthenia gravis or Eaton Lambert syndrome
* Inflammatory myositis \<2 years or pre-existing motor neurone disease or upper limb motor neuropathy
* Reported allergy or hypersensitivity to any Botulinum toxin preparation or to lidocaine or other local anesthetic agent or to albumin or to inhaled nitrous oxide/oxygen.
* Active infection in either hand.
* Pregnant or lactating women (women of child bearing potential must undergo a urine pregnancy teste before inclusion and at treatment day).
* women of child bearing potential without medically accepted method of birth control
* Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomy or ever received botulinum toxin or planned to receive botulinum toxin in the next 6 months
* Cognitive impairment
* Iloprost scheduled the month following injections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03717961
Study Brief:
Protocol Section:
NCT03717961