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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Sarecycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarecycline<br>Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment. | Drug: Sarecycline<br>* Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.<br>* Other names: Seysara®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) for PROs Assessment |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Facial IGA success at Week 12, defined as a 2-point decrease in IGA score from baseline and a score of 0 (clear) or 1 (almost clear). |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective, Non-nodular Acne Vulgaris, Perceptions, Health-Related Quality of Life (HRQoL), Patient-Reported Outcomes (PROs), Signs & Symptoms