A Prospective Randomized Trial Comparing Quality of Life in Adult Female Acne Treated with Azelaic Acid 15% Gel versus Oral Spironolactone

Diogo Pazzini Bomfim,1 Marco Alexandre Dias da Rocha,2 Adriana Sanudo,3 Edileia Bagatin2 1Translational Medicine, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil; 2Department of Dermatology, Federal University of Sao Paulo (UNIFESP), Sao Paulo, Brazil; 3Department of Preventive medicine, Federal University of Sao Paulo (UNIFESP), Sao Paulo, BrazilCorrespondence: Diogo Pazzini Bomfim, Email [email protected]: In several countries, recent research has shown an increase in the prevalence of adult female acne (AFA), defined as the acne that appears in women aged over 25. This disease brings some particularities and challenges, such as a greater impact on quality of life (QoL) and chronicity. A negative impact on QoL has been observed, as well as anxiety, depression, anger, low self-esteem, and feelings of embarrassment and frustration.Purpose: To quantify AFA’s impact on QoL and the influence of two dermatological treatments.Material and Methods: A prospective study including 40 women, aging from 25 to 44 years old, with mild-to-moderate acne was conducted. Participants underwent clinical, laboratory, and photographic evaluations. They were randomized into two treatment groups: group 1 – azelaic acid (AZA) 15% gel twice daily; group 2 – spironolactone (SPIRO) 100 mg/day and treated for 6 months. At baseline and at the end of treatments, a specific QoL questionnaire for acne, already translated and validated for Brazilian Portuguese (Acne-QoL-BR), was applied. It contains 19 questions allotted in four domains. Each item within a domain is scored from 0 to 6. The total score ranges from 0 to 114 and domains are distributed as follows: 0– 30 (self-perception), 0– 30 (role-emotional), 0– 24 (role-social), 0– 30 (acne-symptoms). Higher scores reflect better QoL.Results: The mean age was 32.7 (SD: 5.42); 85% presented persistent acne. After treatment regardless of group, there was a significant improvement in total score and all domains’ scores of acne QoL-BR (p < 0.001), with no difference between groups, despite one treatment being topical and the other systemic (p=0.918).Conclusion: Acne-QoL-BR is a useful tool for quantifying the impact of acne and should be used as an efficacy parameter in clinical trials.Keywords: adult female acne, quality of life, azelaic acid, spironolactone