F scientific information Melasma and Quality of Life A publication of Galderma Brazil Ltda. Year II. Number 04.

June 2006 Melasma and Quality of Life by Tania Ferreira Cestari and Fernanda Freitag Magagnin Tania Ferreira Cestari Fernanda Freitag Magagnin In the last two decades, there is growing concern regarding the negative impact of diseases on the quality of life of patients. In this field, dermatology disti nguished by some peculiarities. Despite the small mortality rates for skin disea ses, the importance of aesthetic appearance makes changes without great clinical significance could negatively influence the daily activities of patients. Thus arose the need to develop standardized instruments, validated and reproducible r esults with them to measure more aspects of the patient-disease, not only to mee t the needs of evidence-based medicine but also to ensure more comprehensive res ults in clinical studies. Such instruments consist of questionnaires that addres s different aspects of the patient's life. The scores can then be compared betwe en groups (intervention versus placebo), at different moments in the life of the same patient (before and after a given treatment) and between patients with dif ferent diseases. Specific questionnaires on quality of life in diseases have bee n developed for various medical fields such as psychiatry (schizophrenia and dep ression), endocrinology (diabetes), rheumatology (rheumatoid arthritis), gynecol ogy (menopause) and oncology. There are validated instruments in dermatology for psoriasis, atopic dermatitis, acne, hives, onychomycosis, lower limb ulcers, pe mphigus, vitiligo, alopecia, Hidradenitis suppurativa suppurative, photodamage, ichthyosis and, more recently, for melasma. Associate Professor of Dermatology, Dermatologist and the Federal University of Rio Grande Master of the Federal University (UFRGS) and Hospital of Rio Grande d o Sul (UFRGS). ClÍnicas de Porto Alegre - RS. Melasma is an acquired pigmentary disease quite prevalent, chronic and relapsing course which provides numerous medical expenses and medications and procedures. Being primarily a skin of the face, even small, discrete patches may provide co nsiderable harm to the welfare of affected infants. In 2003, Balkrishnan et al. developed and validated the Melasma Quality of Life Scale (MELASQoL), a question naire with ten specific items for measuring the quality of life of patients with melasma. This instrument was made from seven issues of scale SKINDEX-16 (questi onnaire on quality of life of patients with skin diseases in general) and three questions in Skin discoloration Questionnaire. The strategy for selection of the questions was the elimination of those known to be uncorrelated to melasma, for example, questions relating to symptoms. The final score of MELASQoL can vary b etween 7 and 70, with higher scores indicating worse quality of life. The author s applied the MELASQoL in 102 American women between 18 and 65 years, earning an average score of 36. The questions posed in this instrument showed high interna l consistency, validity and good discriminatory power when compared with other q uestionnaires (DLQI and SKINDEX-16). This shows that this instrument can also be used for other skin diseases with similar evolutionary aspects. F

scientific information 1 However, the application of MELASQoL in countries with different language than t he original requires, apart from its correct translation, a complete cultural ad aptation in order to allow homogeneous has applicability to all individuals in t he country, generating results that follow a regular statistical criterion. Thus , the creation of version MELASQoL for Portuguese spoken in Brazil (MELASQoL-BP) followed all the steps recommended by the World Health Organization (WHO). So, first, two independent translators made literal translations of the scales. Then a group of bilingual health professionals (dermatologists, medical students, nu rse and psychiatrist) selected the most appropriate terms and drafted the first version of the questionnaire was applied and reviewed by ten volunteers with mel asma, creating the second version in Portuguese . A third translator performed t he back translation into English, which was submitted to the author's original w ork (Balkrishnan R) for comments and suggestions. The final version was composed of all items with at least 70% agreement between the authors and is now available for use (Ta ble 1). In 2005, we applied the MELASQoL-BP in 84 women with melasma who sought treatment at the Hospital de Clinicas de Porto Alegre.€In this sample, the aver age score of MELASQoL _-BP was 37.5 (SD + 15.2), similar to that found by the au thors of the original questionnaire. The domains of quality of life most affecte d by melasma were those related to emotional well-being of patients. This was ev idenced by the worst result in issues related to the appearance of the skin, fru stration and embarrassment due to illness. As in the original study, there was n o correlation between poorer quality of life and greater severity of lesions (r = 0.17, P = 0.109). This finding reinforces the idea that patients using criteri a other than severity of illness in assessing their impact on quality of life. T hus it is possible to misidentify a patient's illness as only a cosmetic nuisanc e, without major repercussions, Table 1 - Version approved MELASQoL for the Portuguese language of Brazil. QUALITY OF LIFE QUESTIONNAIRE FOR PATIENTS WITH MELASMA (MELASQoL-BP) Considering his illness, melasma, last week before this query, how do you feel a bout: 1. The appearance of your skin. 2. Frustration at the condition of your sk in. 3. Embarrassed by the condition of your skin. 4. Feeling depressed by the co ndition of your skin. 5. The effects of the condition of your skin in relationsh ip with others (eg interactions with family, friends, intimate relationships, et c.).. 6. The effects of your skin condition on your desire to be with people. 7. The condition of your skin makes it difficult to show affection. 8. Spots on th e skin make you feel not attractive to others. 9. Spots on the skin make you fee l less important or productive. 10. The skin blemishes affect your sense of free dom. Not a bit annoyed not bothered January 1 in most cases 2 2 Not bothered som etimes troubled sometimes March 3 May 5 Bothered most of the time June 6 bothere d all the time Neutral April 4 July 7 1 2 3

4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5

6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 1 2 3 4 5 6 7 * With consent and approval of the original author - Rajesh Balkrishnan. F scientific information when in fact it has caused losses in interpersonal relationships, work, and espe cially on self-esteem. This means that treatment decisions should not be based s olely on clinical features of disease, but also in its psychological aspects. Th us, the quality of life measured using specific scales emerge as an important ou tcome in clinical research, particularly in the field of dermatology. The trial PIGMENT (Prospective Investigation Gauging Melasma Reduction with a New Treatmen t) is the first published study that recommends the measurement of quality of li

fe before and after treatment of patients with melasma. This multicenter, open-l abel, Phase IV, included 1290 volunteers of both sexes aged over 18 years. Patie nts were instructed to apply once a day, a cream containing fluocinolone 0.01%, hydroquinone 4% and tretinoin 0.05% in the affected areas. Treatment efficacy wa s assessed at weeks 4 and 8, using the scale MASI (Melasma Area and Severity Ind ex). Quality of life was measured before and after 8 weeks of treatment through the Patient Health Questionnaire and Skin discoloration Impact Evaluation Questi onnaire and the second exclusively created for the study, with some items simila r to MELASQoL. The study treatment resulted in significant reduction of the aver age MASI score over the eight weeks (MASI pretreatment = 14.68, 7.38 at week 4, 3.64 at week 8; p <0.0001). In evaluating the quality of life, most patients included in 1076 re ported decreased embarrassment on melasma, reduction in the use of cosmetics and fewer attempts to hide the stains. Many feel young and attractive. The MELASQoL -BP is a simple questionnaire and easy to apply, providing valuable information about the emotional impact caused by melasma on patient's life. He is already in the process of national validation and will certainly enable a broader assessme nt of the therapeutic results, fulfilling important aspects of the physician-pat ient disease. In 2006, a study was conducted in ten Brazilian centers involving over 180 patients to evaluate the impact of melasma on quality of life of Brazil ians. The results were surprising and will be published soon in a magazine of wi de circulation in the middle of dermatology. Below some of these findings: a) 91 .3% of patients felt uncomfortable with the appearance of skin b) 80.7% of patie nts felt frustrated with proper skin condition, c) 794% felt embarrassed by the condition of your skin, d) 50.3% felt depressed. References: 1. Balkrishnan R, McMichael AJ, Camacho FT, Saltzberg F, Housman TS, GRUMMER S e t al. Development and validation of a health-related quality of life instrument for women with melasma. Br.J Dermatol. 2003; 149:572-7. 2. FINLAY AY, KHAN GK. D ermatology Life Quality Index (DLQI)-A Simple Practical Measure for routine clin ical use. Clin.Exp.Dermatol. 1994; 19:210-6. 3. FLECK M, Leal O, S LOUZADA, XAVI ER M, CHACHAMOVICH E, Vieira G et al. Development of the Portuguese version of t he instrument for assessing quality of life in WHO (WHOQOL-100). Rev Bras Psiqui atr .1999; 21:19-28. 4. Guillemin F, Bombardier C, D. BEATON CROSS cultural adap tation of health-related quality of life measures: literature review and Propose d guidelines. J Clin.Epidemiol. 1993; 46:1417-32. 5. HALIOUA B BEUMONT MG, Lunel F. Quality of life in dermatology. Int.J Dermatol. 2000; 39:801-6. 6. MARTINS G A, Arruda L, MUGNAINI ASB. Validation of life quality questionnaires. An Bras De rmatol 2004; 79:52133. 7. The World Health Organization Quality of Life assessme nt (WHOQOL): position paper from the World Health Organization. Soc.Sci.Med 1995 ; 41:1403-9. 8. CESTARI TF, Balkrishnan R, Weber MB, PRATI C MENEGON DB, MAZZOTT I NG, Trojan C. Translation and cultural adaptation to portuguese of a quality o f life questionnaire for patients suffering from Melasma. Med Cut Ibero Lat Amer in press. F scientific information Year II. Number 04. Scientific Publishing in June 2006: Maria Regina Shimizu Edi torial Director: Magali A. Luiz Martins Review: L. Renata Pezzolo Pavanelli Grap hic Design: Duoeme Brazil Prepress: ABC Studio Print: Aquaprint Gráfica & Edito ra Ltda. Circulation: 5,000 copies exclusive National distribution: Galderma Bra zil Ltda. Melasma in Focus - the publication of Galderma Brazil Ltda .- aims at informing and updating the class dermatological and aims to be a useful tool for applicati on in daily clinical specialist. All rights reserved by Galderma Brazil Ltda. Re

production of any part of this publication without prior permission of the publi sher of science. Letters, suggestions, comments, and materials for scientific an alysis of the feasibility of publication should be sent to Docket Rodrigo: @ rod rigo.martins galderma.com F scientific information 3