NCT04820673

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Sarecycline	Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.

Timeline

• Start date: 2021-03-09
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2021-03-29
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study