Status:
COMPLETED
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
Lead Sponsor:
Almirall, S.A.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9+ years
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 ...
Eligibility Criteria
Inclusion
- Patient
- 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
- Primary caregiver of the study-eligible patient
- Male or female, aged 18 years and above
Exclusion
- 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
Key Trial Info
Start Date :
March 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04820673
Start Date
March 9 2021
End Date
May 4 2022
Last Update
October 10 2024
Active Locations (2)
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1
Almirall Site#2
Boston, Massachusetts, United States, 02116
2
Almirall Site #1
Brooklyn, New York, United States, 11201