Systemic SclerosisPREVISSNCT05177380
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
A study testing Personalized rehabilitation program of facial involvement in systemic sclerosis and Delivery of a standard prescription for facial rehabilitation in people with Systemic Sclerosis and Face, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Face, Facial Involvement
- What is being tested?
- Personalized rehabilitation program of facial involvement in systemic sclerosis and Delivery of a standard prescription for facial rehabilitation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Previous participation in a rehabilitation program of facial involvement
- Patient under legal protection
- Impossibility to give clear information of subject
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaire de Strasbourg
Strasbourg, Bas-Rhin, 67300
DELORME, +33388115415, dpidrci@chru-strasbourg.fr
About this study
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.
Read more
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.
- Conditions
- Systemic Sclerosis, Face, Facial Involvement, Rehabilitation
- Being tested
- Personalized rehabilitation program of facial involvement in systemic sclerosis, Delivery of a standard prescription for facial rehabilitation
- Keywords
- Face, Facial involvement, Rehabilitation, Systemic sclerosis
- Medical subject headings
- Scleroderma, Systemic, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized rehabilitation program of facial involvement in systemic sclerosisProcedure or surgery
Personalized rehabilitation program of facial involvement in systemic sclerosis
Delivery of a standard prescription for facial rehabilitationOther
Delivery of a standard prescription for facial rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Personalized rehabilitation program of facial involvement in systemic sclerosis | Experimental | 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 Receives: Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis |
| Routine care | Other | Delivery of a standard prescription for facial rehabilitation Receives: Other: Delivery of a standard prescription for facial rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Measured: Week 6
Secondary outcomes (18)
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Measured: Week 2
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Measured: Week12
Interincisal distance measurement
Interincisal distance measurement in mm
Measured: Week 6
Interincisal distance measurement
Interincisal distance measurement in mm
Measured: Week 12
Rodnan skin score on the face
a measure of skin thickness
Measured: Week 6
Rodnan skin score on the face
a measure of skin thickness
Measured: Week 12
Visual Analog Scale (VAS) for pain
Measured: Week 2
Visual Analog Scale (VAS) for pain
Measured: Week 6
Visual Analog Scale (VAS) for pain
Measured: Week12
HAQ questionnaire
Health Assessment Questionnaire
Measured: Week 6
HAQ questionnaire
Health Assessment Questionnaire
Measured: Week 12
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Measured: Week 6
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Measured: Week 12
Weight
Weight in kg
Measured: Week 12
Total number of rehabilitation sessions
Measured: Week 6
Total duration of rehabilitation sessions
Measured: Week 6
Total number of rehabilitation sessions
Measured: Week 12
Total duration of rehabilitation sessions
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start13 Oct 2022
- Primary completionNov 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177380
- Sponsor's protocol ID
- 8072
- Other IDs
- 2020-A03314-35
- Acronym
- PREVISS
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05177380
- Acronym / sponsor ID
- PREVISS / 8072
- Conditions
- Systemic Sclerosis, Face, Facial Involvement, Rehabilitation
- Keywords
- Face, Facial involvement, Rehabilitation, Systemic sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized rehabilitation program of facial involvement in systemic sclerosis | Experimental | Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis3 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 |
| Routine care | Other | Other: Delivery of a standard prescription for facial rehabilitationDelivery of a standard prescription for facial rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Previous participation in a rehabilitation program of facial involvement
- Patient under legal protection
- Impossibility to give clear information of subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized rehabilitation program of facial involvement in systemic sclerosisPersonalized rehabilitation program of facial involvement in systemic sclerosis | Procedure or surgery | Personalized rehabilitation program of facial involvement in systemic sclerosis |
| Delivery of a standard prescription for facial rehabilitationDelivery of a standard prescription for facial rehabilitation | Other | Routine care |
Primary outcome
Mouth Handicap In Systemic Sclerosis (MHISS) score
Time frame: Week 6
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
18 secondary outcomes
Mouth Handicap In Systemic Sclerosis (MHISS) score
Time frame: Week 2
Mouth Handicap In Systemic Sclerosis (MHISS) score
Time frame: Week12
Interincisal distance measurement
Time frame: Week 6
Interincisal distance measurement
Time frame: Week 12
Rodnan skin score on the face
Time frame: Week 6
Rodnan skin score on the face
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
Time frame: Week 6
HAQ questionnaire
Time frame: Week 12
SF12 questionnaire (12-item Short Form Survey)
Time frame: Week 6
SF12 questionnaire (12-item Short Form Survey)
Time frame: Week 12
Weight
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized rehabilitation program of facial involvement in systemic sclerosis and Delivery of a standard prescription for facial rehabilitation in people with Systemic Sclerosis and Face, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel CHATELUS, MD (+33 3 88 12 71 40, emmanuel.chatelus@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Handicap In Systemic Sclerosis (MHISS) score (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.