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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT05857358
Eligibility Criteria:
Inclusion Criteria:
* Patients from 18 to 65 years.
* Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...)
* Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60
* Informed consent to participate (with signature)
* Negative β -HCG test and effective contraception for women being able to get pregnant
* Affiliation to the social security system
Exclusion Criteria:
* Medical history of head and neck neoplasia
* Recent (\<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics
* Body Mass Index \< 18
* Active smoking (\> 5 cigarettes a day)
* Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL)
* Coagulation disorders including anticoagulant and antiplatelet treatment
* Any temporary or definitive contraindication due to any medical or surgical unstable condition
* Allergy to local anesthesia and/or albumin
* Pregnant or breastfeeding women
* Adult protected by the law (tutorship and curatorship)
* Patients already enrolled in another study
* Patients under 18 years of age
* Person deprived of liberty
* Patient non-affiliated to the social security
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05857358
Study Brief:
Protocol Section:
NCT05857358