An interventional study of Personalized rehabilitation program of facial involvement in systemic sclerosis and Delivery of a standard prescription for facial rehabilitation in Systemic Sclerosis, Face and Facial Involvement, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Treatment
Among 132 studies in Scleroderma, Systemic with a site in France — 44 open to participants now, 48 under way, 7 of them phase 3. Scleroderma, Systemic · France.
Among the 132 studies in Scleroderma, Systemic with a site in France, this one is the 46th largest by planned enrollment of the 81 interventional ones, is one of 10 that started in 2022, is one of 35 with no phase, reaches primary completion later than 35 of the 47 other live ones, and was the 86th registered.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 60 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →44 of the 132 studies in Scleroderma, Systemic with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 144 Scleroderma, Systemic studies recruiting now, 82 (57%) set no upper age limit and 49 (34%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →132 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 10 started in 2022.
Median enrollment 75 across the 81 interventional studies, 150 across the 50 observational. Of the 70 that completed or were terminated, 8 (11%) have results posted.
24 of 132 have an industry lead sponsor. The 10 most frequent:
University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
University Hospital, Strasbourg, France has 8 studies filed under Scleroderma, Systemic — fewer than ten, so there is no comparison to draw.
7 of the studies in Scleroderma, Systemic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06655155argenxA Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis | 2027-03 |
| NCT04356755University Hospital, ToulouseSubcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. | 2027-03 |
| NCT07888842Assistance Publique - Hôpitaux de ParisA Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status. | 2027-05 |
| NCT07543679Centre Hospitalier Universitaire de Saint EtienneObjective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis | 2027-05-01 |
Among the 132 studies in Scleroderma, Systemic with a site in France, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 sessions of 2 hours of facial rehabilitation in hospital over 2 weeks including: * Physiotherapy with facial and endo-oral massages, self-massages, active and passive exercises of the face and mouth, tongue exercises * Speech therapy with mobilization of the orofacial sphere applied to swallowing and speech difficulties * Individual workshop on the theme of dry mouth, dry mouth, swallowing disorders, and oral care * Individual therapeutic makeup workshop * A motivational interview * A patient notebook with a personalized protocol for self-rehabilitation of the face * A video tutorial for self-rehabilitation of the face Facial self-rehabilitation sessions at home
Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis
Delivery of a standard prescription for facial rehabilitation
Other: Delivery of a standard prescription for facial rehabilitation
Personalized rehabilitation program of facial involvement in systemic sclerosis
Delivery of a standard prescription for facial rehabilitation
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 6
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 2
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week12
Interincisal distance measurement
Interincisal distance measurement in mm
Time frame: Week 6
Interincisal distance measurement
Interincisal distance measurement in mm
Time frame: Week 12
Rodnan skin score on the face
a measure of skin thickness
Time frame: Week 6
Rodnan skin score on the face
a measure of skin thickness
Time frame: Week 12
Visual Analog Scale (VAS) for pain
Time frame: Week 2
Visual Analog Scale (VAS) for pain
Time frame: Week 6
Visual Analog Scale (VAS) for pain
Time frame: Week12
HAQ questionnaire
Health Assessment Questionnaire
Time frame: Week 6
HAQ questionnaire
Health Assessment Questionnaire
Time frame: Week 12
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Time frame: Week 6
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Time frame: Week 12
Weight
Weight in kg
Time frame: Week 12
Total number of rehabilitation sessions
Time frame: Week 6
Total duration of rehabilitation sessions
Time frame: Week 6
Total number of rehabilitation sessions
Time frame: Week 12
Total duration of rehabilitation sessions
Time frame: Week 12
Started Oct 2022 (actual). Primary completion is estimated for Nov 2029, 85 months after the start.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 85 months is above that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Strasbourg, France →