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

Sponsor

Almirall, S.A. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04820673

Collaborator

(none)

300

Enrollment

Locations

12.3

Anticipated Duration (Months)

150

Patients Per Site

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Sarecycline

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 24, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Sarecycline

Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment.

Drug: Sarecycline

Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.

Other Names:

Seysara®

Outcome Measures

Primary Outcome Measures

Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) for PROs Assessment [Baseline, Week 12]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years and Older

Sexes Eligible for Study:

All

Accepts 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