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

A Real-world Prospective Cohort Study of Patients With Moderate to Severe Acne Vulgaris Treated With Sarecycline (Seysara®) In Community Practice Settings in the U.S

The purpose of this study is to evaluate the patient-reported outcomes (PROs) in terms of health-related quality of life (HRQoL) and signs of Acne Vulgaris (AV) among patients with moderate to severe non-nodular AV who are administered sarecycline (Seysara®) in real-world community practice settings in the United States (U.S). Investigator's Global Assessment (IGA) of AV and safety measures associated with use of sarecycline (Seysara®) will be assessed over the study observation period of 12 weeks. Clinicians will prescribe sarecycline (Seyara®) as per their own clinical judgment and standard practice.

Inclusion Criteria:

Patient Inclusion Criteria:

• Male or female, aged 9 years and above
• Has facial non-nodular AV with IGA score of moderate or severe
• Considered as a potential candidate for sarecycline (Seysara®) treatment, per clinician judgment

Caregiver Inclusion Criteria:

• Primary caregiver of the study-eligible patient
• Male or female, aged 18 years and above

Exclusion Criteria:

• Patients with any known resistance to other tetracyclines
• Patients with any dermatological or physical condition of the face that could interfere with the AV clinical evaluations.
• Patients with any history of allergy to tetracycline-class antibiotics, pseudomembranous colitis or antibiotic-associated colitis.
• Unable to comply with the requirements of the study or patients who in the opinion of the Site Investigator should not participate in the study

Other protocol defined Inclusion/Exclusion criteria may apply