Introduction: Scarring on visible areas such as the face is associated with negative psychological impact. Many patients with acne have clinically relevant scarring for which they seek treatment, implying that there is an impact on their lives. Currently there are no validated tools to assess the burden of atrophic acne scarring from the patient's perspective or to assess treatment benefit.
Methods: Two patient-reported outcome measures, the self-assessment of clinical acne-related scars (SCARS) and the facial acne scar quality of life (FASQoL) tools, both specific to facial atrophic acne scarring, were developed according to Food and Drug Administration guidance methodology. Patient interviews were conducted first to elicit patient-important concepts about scarring, then to validate patients' understanding of wording in the tools. These tools focus on symptoms (SCARS) and psychological and social well-being (FASQoL) and were designed to be suitable for self-completion and to be rapidly completed (2-5 min) within a clinical research setting.
Results: Concept elicitation interviews were conducted with 30 subjects and cognitive interviews with 20 subjects. With acne scarring, important concepts for patients included size, surface area affected, counts, and depth. The SCARS and FASQoL tools were shown to address relevant concepts that were easily understood by patients.
Conclusion: Two patient-reported measures, SCARS and FASQoL, have been developed to help clinicians assess the severity and impact of acne scars. Responsivity of these instruments to treatment will require further evaluation.
Funding: Galderma R&D, Sophia Antipolis, France.
Keywords: Acne; Atrophic scar; Patient-reported outcome measure; Quality of life; Scar assessment.