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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04820673
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

Study Description
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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 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.

Condition or disease Intervention/treatment
Acne Vulgaris Drug: Sarecycline

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Groups and Cohorts
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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 Name: Seysara®


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) for PROs Assessment [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820673


Contacts
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Contact: Èric Massana 0034 932 913 986 eric.massana@almirall.com

Locations
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United States, Michigan
Almirall Site#2 Recruiting
Woodhaven, Michigan, United States, 48183
United States, Ohio
Almirall Site #1 Recruiting
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Almirall, S.A.
Investigators
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Study Director: Study Director Almirall, S.A.
More Information
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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT04820673    
Other Study ID Numbers: M-24001-40
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Almirall, S.A.:
Prospective
Non-nodular Acne Vulgaris
Perceptions
 Health-Related Quality of Life (HRQoL)
Patient-Reported Outcomes (PROs)
Signs & Symptoms
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
 Sarecycline
Anti-Bacterial Agents
Anti-Infective Agents
Dermatologic Agents