Title

LB756 Patient-reported outcomes for sarecycline effectiveness in Acne Vulgaris in real-world settings: PROSES study protocol

Document Type

Conference Proceeding

Publication Date

9-1-2021

Publication Title

J Invest Dermatol

Abstract

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.

Volume

141

Issue

9

First Page

B12

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