Validation of a melasma quality of life questionnaire for Brazilian Portuguese language: the MelasQoL-BP study and improvement of QoL of melasma patients after triple combination therapy

Background Pigmentation disorders, such as melasma, greatly influence the quality of life (QoL) of affected individuals who usually consider the disorder to be more severe than the objective clinical scores. Several instruments have been successfully developed to evaluate QoL. However, they must be adapted to the target population in terms of language and cultural diversity. The first, specific QoL questionnaire for melasma (MelasQoL) was developed for English speaking patients. Objectives To validate the Brazilian Portuguese version of the MelasQoL evaluation questionnaire for patients with melasma (MelasQoL-BP) and to assess the impact of treatment with a triple combination cream (hydroquinone, fluocinolone acetonide and tretinoin) on the QoL of patients with moderate-to-severe melasma. Methods and Results Three hundred individuals from the five Brazilian geographic regions took part in this multicentre study. Their mean age was 42 years and skin phototype distribution was: type II 7.0% of patients, III 23.7%, IV 42.7% and V 22.7%. Melasma Area and Severity Index (MASI), MelasQoL-BP and the short version of the QoL assessment instrument from the World Health Organization (WHOQOL-BREF) were used to assess melasma severity and QoL at baseline. MelasQoL-BP was previously translated and culturally adapted from the English version, with participation of the authors and according to the standards of the World Health Organization (WHO). From the original sample, we randomized150 volunteers to treat melasma and repeated the evaluation after 8 weeks. The analysis of the MelasQoL-BP baseline answers demonstrated an important impact of the disease on skin appearance (65% of patients were bothered all the time or most of the time), frustration (55%), embarrassment (57%) and influence of the disease on interpersonal relationships (42%). Forty-three per cent of patients felt not attractive or even dirty due to their skin condition. MelasQoL-BP results showed significant internal consistency (Cronbach's alpha coefficient 0.919; P < 0.001) and good correlation with MASI scores. After treatment, the global assessment showed good or excellent results in 91.4% of the patients. The clinical outcome was not associated with the initial MASI score (P = 0.814; chi-square), skin colour (P = 0.449; probability ratio) or skin pigmentation (P = 0.814; chi-square). There was also a significant reduction on MelasQoL-BP scores (Wilcoxon test; P < 0.001) after treatment, with the mean +/- SD results shifting from 44.4 +/- 14.9 at baseline to 24.3 +/- 15.5 after treatment. The analysis of the MelasQoL-BP before and after treatment showed an important effect of the impact of treatment on a number of QoL measures. Of note, skin appearance (69.8 vs. 10.1% of patients were bothered all the time or most of the time, respectively), frustration (59.7% vs. 12.2%, respectively), embarrassment (56% vs. 9.3%, respectively) and influence of the disease on interpersonal relationships (35.3% vs. 5.8%, respectively) were greatly improved. Conclusion This study demonstrates that MelasQoL-BP is a valid instrument and can be used to evaluate the quality of life and response to melasma treatment in Brazilian patients. The triple combination treatment produced significant results, regarding both clinical severity and quality of life.