N/A
N=300
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT04820673 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Oct 2024
Primary outcome: Primary: Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 — 1.96; -0.77; 2.06; -1.01 Score on a Scale — p=<.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sarecycline (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Almirall, S.A.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 |
1.96; -0.77; 2.06; -1.01; 2.43; -1.15 | <.0001 sig |
| SECONDARY Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 |
58.89 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04820673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.