Abstract
INTRODUCTION: Acne scarring is one of the primary sequelae that affect patients with acne, with facial scarring occurring to some extent in 95% of patients with active acne. Subtypes include atrophic, hypertrophic and keloid scarring. Treatment options include topical and surgical approaches. Despite numerous clinical trials focusing on acne scarring treatments, the absence of standardised outcome reporting across these trials raises concerns in evaluating treatment methods. To address this issue, this project aims to develop a core set of outcomes which should be uniformly assessed in all clinical trials involving acne scarring. METHODS AND ANALYSIS: Outcomes will be extracted from four sources: a systematic literature review, patient interviews, printed and electronic sources and stakeholder involvement. The steering committee will assess the potential outcomes, adding or removing outcomes if needed. The Delphi process will be performed to understand the importance of outcomes. Two rounds of Delphi surveys will be completed by physicians, researchers and patients. Following this, a consensus meeting involving stakeholders will be held to refine the outcomes based on participant scores. The meeting will end in a voting process to determine a final recommended core outcome set (COS). This study will be conducted in collaboration with the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the CHORD COUSIN Collaboration (C3). This study aims to develop a global COS to standardise assessment approaches in clinical trials of acne scarring. The final goal is to enhance uniformity of outcome reporting. ETHICS AND DISSEMINATION: Ethical approval and consent to participate for the study have been granted by Northwestern University Institutional Review Board protocol ID: STU00097285. On completion of the COS, we plan to publish our results in peer-reviewed journals and send participants the finalised COS. PROSPERO REGISTRATION DETAILS: This study is registered with PROSPERO (CRD42023460964), COMET (754) and C3 (https://www.c3outcomes.org/improved-acne-scarring).