Abstract

To investigate the effect of cosmetic camouflage in health-related quality of life (HRQoL) in women with systemic lupus erythematosus (SLE) and permanent facial skin damage. This is a randomized controlled clinical trial (Universal Trial Number: U1111-1210-2554e) with SLE women from outpatients using ACR/1997 and/or SLICC/2012 criteria, aged over 18 years old, with modified SLEDAI 2k < 4 and permanent facial skin damage, recruited in two tertiary centers to use cosmetic camouflage (n = 36) or no intervention (n = 20). Endpoints were score variations in SLE Quality of Life (SLEQoL) (total and each domain), Dermatology Life Quality Index (DLQI), Rosenberg self-esteem scale and Hospital Anxiety and Depression Scale (HADS), after daily use of cosmetic camouflage for 12 +/-2 weeks (Phase I), "as needed" use of cosmetic camouflage for another 12 +/-2 weeks (Phase II), and during total follow up (24 +/-2 weeks). Univariate and multivariate linear regressions were conducted by protocol analysis. Both groups were similar at baseline regarding age, disease duration, socio-demographic, clinical, laboratory and treatment characteristics. The comparison of score variations between intervention and control groups showed an independent HRQoL improvement in total SLEQoL score after using cosmetic camouflage in Phase I [β -27.56 (CI 95% -47.86 to -7.27) p = 0.009] and total follow up [β -28.04 (CI 95% -48.65 to -7.44) p = 0.09], specifically in mood, self-image and physical functioning domains. Also, there was an improvement in DLQI scores during Phase I [β -7.65 (CI 95% -12.31 to -3.00) p = 0.002] and total follow up [β -8.97(CI95% -12.99 to -4.94) p < 0.001). Scores for depression [β -1.92 (CI 95% -3.67 to -0.16) p = 0.033], anxiety [β -2.87 (CI 95% -5.67 to -0.07] p = 0.045] and self-esteem [β 2.79 (CI 95% 0.13 to 5.46) p = 0.041] improved considering the total follow up. No significant changes occurred in the control group scores. The use of cosmetic camouflage improved the HRQoL in female SLE patients with permanent facial skin damage.

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