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

N/ACompletedNCT04820673

Almirall, S.A.300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Acne Vulgaris

Interventions

SarecyclineDRUG

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

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

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

Locations (2)

Almirall Site#2

Boston, Massachusetts, United States

Almirall Site #1

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12

Patient related outcome (PROs) assessment performed using ASIS Questionnaire, a 17-item questionnaire that asks participants about the signs, impact (emotional and social) of AV, responses were reported as two scales: Signs (9 items), and Impact (8 items). Impact domain had two sub-scales, pertinent to Emotional (6 items) and Social impact (2 items). All items are scored on a 5-point scale: 0 (best) to 4 (worst). A domain score is determined by the average of scores in each scale within the domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.

Time frame: Baseline, Week 12

Secondary Outcomes

Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12

The investigator assessed the participant's facial acne using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). Percentage of participants who achieved facial IGA success at Week 12 were reported.

Time frame: At Week 12

Data from ClinicalTrials.gov

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