Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)

Patient related outcome (PROs) assessment performed using ASIS Questionnaire, a 17-item questionnaire that asks participants about the signs, impact (emotional and social) of AV, responses were reported as two scales: Signs (9 items), and Impact (8 items). Impact domain had two sub-scales, pertinent to Emotional (6 items) and Social impact (2 items). All items are scored on a 5-point scale: 0 (best) to 4 (worst). A domain score is determined by the average of scores in each scale within the domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.

The investigator assessed the participant's facial acne using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). Percentage of participants who achieved facial IGA success at Week 12 were reported.