Abstract Background/Aims Orofacial complications cause major morbidity in systemic sclerosis (SSc) affecting appearance, mouth opening, saliva production and psychological wellbeing. Previous uncontrolled studies suggest benefit from autologous lipotransfer. We report the results of the first prospective randomised clinical trial comparing facial lipotransfer with routine care. Methods This was a prospective randomised feasibility study comparing lipotransfer and “treatment as usual” (TAU) with change in Mouth Handicap in Systemic Sclerosis scale (MHISS) at 6 months as primary endpoint, using a linear regression model to account for baseline MHISS score. Secondary endpoints included recruitment rate and attrition, willingness to be randomised, mouth opening, stimulated salivary flow rate, Derriford Appearance Scale (DAS24), Brief Fear of Negative Evaluation Scale (BFNE) and Hospital Anxiety and Depression Scale (HADS). Results Of 77 patients approached, 50 consented (consent rate of 63%, 95% CI: 52.6%,73.9%). Forty-nine passed eligibility screening, and 41 completed 6-month follow-up, including 20 in the intervention arm and 21 controls (TAU). In the intervention group median (IQR) age was 54.5 years (46.0, 60.5), 11 (46%) had diffuse cutaneous (dc)SSc, and 10 were taking immunosuppressant treatment (IST). In the control arm age was 47.5 years (41.0, 55.0), 13 (52%) had dcSSc and 17 (71%) were on IST. Treatment effect on the MHISS primary endpoint was statistically significant (p = 0.011) with estimate -5.04 (CI -8.74 to -1.34). 10 (4 control, 6 intervention) observations were omitted due to missingness. Primary and secondary endpoint data are summarised in Table 1. Significant improvement favouring lipotransfer was observed for secondary endpoints including MHISS at 3 months, and improvement in mouth opening distance, improvement in stimulated salivary flow and improvement in psychological functioning (DAS24, BFNE and HADS) at 6 months. Conclusion Our findings confirm significant improvement in MHISS after stem cell enriched autologous lipotransfer to treat orofacial SSc. Significant improvement favouring stem cell enriched autologous lipotransfer was found in patient mouth opening and psychological outcomes at 6 months. Current incorporation of this surgical intervention into routine care is supported and further studies to assess optimal delivery and biological mechanism should be undertaken. Understanding the underlying biological mechanism may lead to a new antifibrotic therapy. Disclosure P.E.M. Butler: None. B. Langridge: None. L. Awad: None. M. Wiengand: None. L. Steblecki: None. R. Ochiel: None. E. Hansen: None. C.P. Denton: Consultancies; Johnson Boehringer Ingelheim, Johnson&Johnson.
Butler et al. (2026) studied this question.