LB756 Patient-reported outcomes for sarecycline effectiveness in Acne Vulgaris in real-world settings: PROSES study protocol
Graber E, Baldwin H, Harper J, Alexis A, Gold LS, Hebert A, Fried R, Rieder E, Kircik L, Del Rosso J, Kasujee I, and Grada A. LB756 Patient-reported outcomes for sarecycline effectiveness in Acne Vulgaris in real-world settings: PROSES study protocol. J Invest Dermatol 2021; 141(9):B12.
J Invest Dermatol
Introduction: The detrimental psychosocial impact of acne vulgaris is well established. Patient-reported outcomes are needed to fully understand the psychosocial benefits of acne treatment. Sarecycline, a novel narrow-spectrum antibiotic, demonstrated efficacy, safety, and improvement in health-related quality of life (HRQOL) in clinical trials and is approved for treatment of moderate-to-severe acne. In 2020, a consensus panel generated a 10-question expert panel questionnaire (EPQ), which, along with the validated acne symptom and impact scale (ASIS), was considered a high-quality tool for real-world assessment of patient-reported HRQOL. The HRQOL benefits of sarecycline will be assessed using these instruments.
Methods: This single-group, prospective, 12-week cohort study is expected to enroll 300 patients (age, ≥9 years) with moderate-to-severe acne treated with sarecycline as part of routine care in up to 50 US community practices. The primary endpoint is patient-reported outcomes at week 12. At the baseline and week-12 visits, patients and caregivers of pediatric patients will complete the EPQ and ASIS. Additional endpoints include sarecycline effectiveness (success on investigator global assessment), satisfaction, safety, and tolerability.
Conclusions: This real-world study of sarecycline will be the first to use the most recent expert panel recommendations to evaluate HRQOL for patients with acne.