Clinical Research Directory

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