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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT04523506
Eligibility Criteria:
Inclusion Criteria:
1. Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 .
2. Male and female subjects.
3. English and non-English speakers.
4. Subjects aged 18 years old to 65 years old will be considered
Exclusion Criteria
1. Patients under 18 years old will be excluded.
2. Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation,
3. Active skin infection at the proposed injection site.
4. Concomitant neuromuscular disorder.
5. Pregnant or lactating.
6. Missing incisors.
7. treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04523506
Study Brief:
Protocol Section:
NCT04523506