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Rehabilitation program for facial problems in systemic sclerosis

Tests a personalized facial rehabilitation program in adults with systemic sclerosis face involvement.

Plain-language title generated from the registry record
Registry title: Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

Key facts

Where
Strasbourg, FranceSee the site

Where in France

  • Hôpitaux Universitaire de StrasbourgStrasbourg, FranceTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University Hospital, Strasbourg, France
Trial code
NCT05177380
Record updated
8 June 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: Previous participation in a rehabilitation program of facial involvement; Pregnancy; Patient under legal protection; Impossibility to give clear information of subject.

ClinicalTrials.gov NCT05177380