NCT05177380Recruiting
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Nov 2021
- Start date
- 13 Oct 2022
- Primary completion date
- Nov 2029
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05177380
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 13 Oct 2022 to the primary completion date, Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in a rehabilitation program of facial involvement
Other
- Pregnancy
- Patient under legal protection
- Impossibility to give clear information of subject
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpitaux Universitaire de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.