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

September 12, 2022 updated by: Almirall, S.A.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Almirall Site#2
    • New York
      • Brooklyn, New York, United States, 11201
        • Almirall Site #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with moderate to severe non-nodular acne vulgaris who are on prescribed sarecycline will be enrolled. Caregivers of eligible pediatric patients will also be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sarecycline
Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment.
Drug: Sarecycline
Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.
Other Names:
  • Seysara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) for PROs Assessment
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almirall, S.A.

Investigators

  • Study Director: Study Director, Almirall, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2021

Primary Completion (Actual)

May 4, 2022

Study Completion (Actual)

May 4, 2022

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-24001-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acne Vulgaris

Clinical Trials on Sarecycline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe