Background Systemic sclerosis is a connective tissue disease which affects blood vessels, the skin and verious internal organs, resulting in articular deformities and possible functional compromission. The mouth, the lips and the face of scleroderma patients are very often altered, with a consequent lowering of the quality of life of the patients who present a smaller mouth opening, altered teeth, lip and mouth dryness, as well as difficulty in masticating and swallowing.
Objectives The aim of the study is to assess the effects of a dermocosmetic “lip balm”, developed by Ekuberg Pharma, on the lips of scleroderma patients through the administration of the Mouth Handicap in Systemic Sclerosis questionnaire (MHISS)1.
Methods This monocentric observational longitudinal trial has been carried out on 39 women affected by scleroderma with skin involvment who were treated with Iloprost once a month at the Department of Rheumatology of “A. Galateo” Hospital in San Cesario di Lecce. The patients were enrolled and diveded into two groups: 18 women followed a specific treatment with the product under investigation, formulated with almond oil, Shea butter, Argan oil and vitamin E. 21 women followed a treatment with a common lip balm based on aloe vera. The patients were instructed to apply daily the product, at least once a day, for a month. The effects of both treatments have been evaluated at T0 and after 30 days (t1) through the Mouth Handicap in Systemic Sclerosis questionnaire (MHISS). The questionnaire aimed at analysing the symptoms related to reduction of mouth opening, dryness (Sicca Syndrome) aMoreover, opportune pictures have been taken.
Results The data obtained from MHISS questionnaires for the study group (SG) showed a very significant improvement (p<0.001) of aesthetic aspects and a significant reduction (p=0.0326) of dryness, in particular with reference to the lips and their moisturization and elasticity level. No significant improvement in the ability to open the mouth was observed (p>0.05). In the control group no significant or very significant improvement has been observed concerning the three parametres. The patients who took part in the trial reported a better quality of life, thanks to the induced aesthetic improvement and less problems to show the face to other people.
Conclusions Thanks to the evaluations obtained from MHISS questionnaire and pictures, the daily use of the cosmetic formulation “lip balm” seems to be useful against discomfort related to lip dryness in woment affected by systemic sclerosis. Significant improvement observed in aesthetic aspects can produce an improvement in the quality of life in terms of interpersonal relationships and spontaneity of behaviour. Furthermore, significant reduction of induced dryness thanks to the treatment with the formulation under investigation is an interesting result to be considered. In order to confirm these results it is necessary to extend the study to a more numerous cohort of patients, assessing the instrumental parametres of moisturization and elasticity of the lips.
Mouthon et al., Development and validation of a scale for mouth handicap in systemic sclerosis: the Mouth Handicap in Systemic Sclerosis, Ann Rheum Dis 2007; 66:1651-1655.
Disclosure of Interest None declared