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Clinical Trials in France / NCT05177380
Recruiting Not applicable

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

NCT05177380 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-10-13
Last updated
2026-06-08

Condition(s) studied

Systemic SclerosisFaceFacial InvolvementRehabilitation

Investigational drug(s) / intervention(s)

Personalized rehabilitation program of facial involvement in systemic sclerosisDelivery of a standard prescription for facial rehabilitation

Personalized rehabilitation program of facial involvement in systemic sclerosis: Personalized rehabilitation program of facial involvement in systemic sclerosis

Delivery of a standard prescription for facial rehabilitation: Delivery of a standard prescription for facial rehabilitation

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpitaux Universitaire de Strasbourg Strasbourg Bas-Rhin Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05177380 on ClinicalTrials.gov ↗ ← All trials in France