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

Acne Vulgaris Clinical Trial

— PROSES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820673
• Other study ID #: M-24001-40
• Status: Completed
• Start date: May 24, 2021
• Est. completion date: May 4, 2022

Study information

• Verified date: September 2022
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Sarecycline
Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.

Locations

Country	Name	City	State
United States	Almirall Site#2	Boston	Massachusetts
United States	Almirall Site #1	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) for PROs Assessment		Baseline, Week 12
Secondary	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