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

Completed

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT04820673

Run by

Almirall, S.A.

People needed

300

Starts

2021-03-09

Expected to finish

2022-05-04

Last updated by the study team

2024-10-10

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Almirall Site#2 — Boston, Massachusetts, United States
• Almirall Site #1 — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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