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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07326033
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient ≥18 years of age,
* Patient with systemic scleroderma according to the 2013 ACR/EULAR classification criteria,
* Mouth Handicap in Systemic Sclerosis Scale (MHISS) score more than or equal to 20 (0-48),
* Rodnan skin score on the face more than or equal to 1,
* Maximal mouth opening of less than 40 mm (distance between the dental arches)
* Patient must have provided written informed consent prior to enrolment,
* Patient must be able to understand their requirements of participating in the protocol.
* Patient affiliated to a social security system.
Exclusion Criteria:
* Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
* Injection of botulinum toxin within 4 weeks prior to "inclusion visit",
* Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,
* Local active labial herpes virus within 1 week prior to "inclusion visit",
* Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),
* History of cancer in the last five years, except for successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had a successful tumor resection or radiation or chemotherapy more than 5 years prior to inclusion and no recurrence, may be enrolled in the study,
* Radio- or chemotherapy in progress,
* Females who are pregnant or breastfeeding or plan to be or do so during the course of this study,
* Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method,
* Vulnerable patient (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07326033
Study Brief:
Protocol Section:
NCT07326033