Abstract

Background: Health-related quality of life (HRQoL) can be negatively impacted by visible skin lesions.1 Objectives: To investigate the effect of cosmetic camouflage on health-related quality of life of systemic lupus erythematosus (SLE) women presenting sequelae of cutaneous manifestations on the face. Methods: This is a randomized controlled clinical trial (Universal Trial Number: U1111-1210-2554e) with outpatients SLE women according to ACR/1997 and/or SLICC/2012 criteria, aged over 18 years old with sequelae of cutaneous lupus manifestations on the face, recruited in two tertiary centers. Exclusion criteria were: moderate to severe systemic lupus activity (SLEDAI 2k-modified>4), no understanding of the questionnaires or psychological and/or psychiatric treatment initiation or modification during the study. A final sample of 43 patients was divided into group I (cosmetic camouflage n=28) and group II (control n=15). Patients in group I were instructed to use cosmetic camouflage daily; Group II patients did not use any camouflage. SLE Quality of Life (SLEQoL) and Dermatology Quality of Life Index (DLQI) questionnaires were used to evaluate HRQoL, higher scores meaning worse HRQoL. All patients answered the questionnaires at baseline (T0) and after 12 (±2) weeks (T1). The primary end point was a change on HRQoL after camouflage cosmetic use. Continuous variables were described as median (interquartile range). The Wilcoxon signed rank test and the Mann-Whitney U test were used for the analysis as indicated. End points were investigated per-protocol analysis, and a 2-sided p value Results: Both groups were similar at baseline regarding age [group I:45.0(37.3-55.7) years old versus group II: 50.0(43.0-55.0) years old, p=0.575], disease duration [group I: 17.5 (7.3-26.5) years versus group II: 15.0 (9.0-17.0) years, p=0.452] and modified SLEDAI-2k [group I: 0 (0-2) versus group II: 2 (0-2), p=0.301]. Also, they were similar considering the sociodemographic, clinical and treatment characteristics of the disease. The DLQI and SLEQoL scores decreased in the cosmetic camouflage group from baseline: DLQI [T0: 8.5 (4.0-16.0) versus T1: 3.0 (1.0-7.5), p=0.008]; SLEQOL [T0: 118.0 (91.0-154.3) versus T1: 95.5 (76.0-135.0), p=0.003]; while there was no variation in the control group: DLQI [T0: 8.0 (3.0-12.0) versus T1: 7.0 (4.0-12.0), p=0.196]; SLEQOL [T0: 89.0 (65.0-127.0) versus T1: 95.5 (65.0-164.0), p=0.532]. The difference on the variations of HRQoL scores between groups I and II was statistically significant: ΔDLQI [group I: -3.0 (-10.8-0.0) versus group II: 1.0 (-1.0-6.0), p=0.003] and ΔSLEQoL [group I:-14.5 (-33.0-0.0) versus group II:3.0 (-8.0-10.0), p=0.009]. The SLEQoL score variations were on physical function (p=0.033), humor (p = 0.033) and self-image (p=0.031) domains. Conclusion: In this group of SLE women with low systemic disease activity and sequelae of cutaneous manifestations on the face, we observed an improvement of HRQoL after daily use of cosmetic camouflage. It is an effective intervention that should be recommended by the rheumatologists.

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