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NCT04820673 · ClinicalTrials.gov registry record
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
A clinical trial, sponsored by Almirall, S.A..
- Completed
- Registry status
- 300
- Enrollment target
NCT04820673: Completed study, sponsored by Almirall, S.A..
NCT04820673 is a clinical trial that has completed, run by Almirall, S.A.. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04820673 has completed, sponsored by Almirall, S.A..
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study 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.
Primary Outcome
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 doma
Interventions
- DRUG Sarecycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-03-09 |
| Est. Completion | 2022-05-04 |
What the finished NCT04820673 record still lists
NCT04820673 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Sarecycline is the first listed.
NCT04820673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04820673 about?
NCT04820673 is a clinical study titled "Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)". 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...
What is the current status of trial NCT04820673?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2021-03-09. Estimated completion is 2022-05-04.
What interventions are being tested in trial NCT04820673?
The interventions under investigation include: Sarecycline (DRUG).
Who is sponsoring clinical trial NCT04820673?
This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.
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