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

Almirall

Status

Completed

Conditions

Acne Vulgaris

Treatments

Drug: Sarecycline

Study type

Observational

Funder types

Industry

Identifiers

NCT04820673

M-24001-40

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

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