NCT05177380 Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
| NCT ID | NCT05177380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-10-13 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-10-13 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss. Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face. Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients. The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 yo * Systemic sclerosis according to the 2013 ACR/EULAR (American College of Rheumatology) classification criteria * Systemic sclerosis with facial involvement defined by a MHISS score \> 6 * Immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month * Subject able to understand the objectives and risks of research and to give informed consent * Subject enrolment in the health insurance scheme Exclusion Criteria: * Pregnancy * Previous participation in a rehabilitation program of facial involvement * Patient under legal protection * Impossibility to give clear information of subject
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05177380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05177380 currently recruiting?
Yes, NCT05177380 is actively recruiting participants. Contact the research team at emmanuel.chatelus@chru-strasbourg.fr for enrollment information.
Where is the NCT05177380 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT05177380 clinical trial?
NCT05177380 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 60 participants.