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NCT Number: NCT05177380

Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, 67300, France

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized rehabilitation program of facial involvement in systemic sclerosis

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

Primary outcomes

  1. Mouth Handicap In Systemic Sclerosis (MHISS) score

    Time frame: Week 6

    A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Secondary outcomes

  1. Mouth Handicap In Systemic Sclerosis (MHISS) score

    Time frame: Week 2

    A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

  2. Mouth Handicap In Systemic Sclerosis (MHISS) score

    Time frame: Week12

    A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

  3. Interincisal distance measurement

    Time frame: Week 6

    Interincisal distance measurement in mm

  4. Interincisal distance measurement

    Time frame: Week 12

    Interincisal distance measurement in mm

  5. Rodnan skin score on the face

    Time frame: Week 6

    a measure of skin thickness

  6. Rodnan skin score on the face

    Time frame: Week 12

    a measure of skin thickness

  7. Visual Analog Scale (VAS) for pain

    Time frame: Week 2

  8. Visual Analog Scale (VAS) for pain

    Time frame: Week 6

  9. Visual Analog Scale (VAS) for pain

    Time frame: Week12

  10. HAQ questionnaire

    Time frame: Week 6

    Health Assessment Questionnaire

  11. HAQ questionnaire

    Time frame: Week 12

    Health Assessment Questionnaire

  12. SF12 questionnaire (12-item Short Form Survey)

    Time frame: Week 6

    a 12-item general health questionnaire

  13. SF12 questionnaire (12-item Short Form Survey)

    Time frame: Week 12

    a 12-item general health questionnaire

  14. Weight

    Time frame: Week 12

    Weight in kg

  15. Total number of rehabilitation sessions

    Time frame: Week 6

  16. Total duration of rehabilitation sessions

    Time frame: Week 6

  17. Total number of rehabilitation sessions

    Time frame: Week 12

  18. Total duration of rehabilitation sessions

    Time frame: Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel CHATELUS, MD

CONTACT

[email protected]

+33 3 88 12 71 40

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PREVISS

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jan 4, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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