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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2022-05-04

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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sarecycline

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

Sarecycline

Intervention Type DRUG

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

Interventions

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Sarecycline

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

Intervention Type DRUG

Other Intervention Names

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Seysara®

Eligibility Criteria

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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

* 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

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No