Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05177380
NA

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-10-13

Completion Date

2029-12

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

PROCEDURE

Personalized rehabilitation program of facial involvement in systemic sclerosis

Personalized rehabilitation program of facial involvement in systemic sclerosis

OTHER

Delivery of a standard prescription for facial rehabilitation

Delivery of a standard prescription for facial rehabilitation

Locations (1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, France