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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04820673
Recruitment Status : Completed
First Posted : March 29, 2021
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

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

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Study Type : Observational
Actual 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
Actual Primary Completion Date : May 4, 2022
Actual Study Completion Date : May 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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®




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


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


Locations
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United States, Massachusetts
Almirall Site#2
Boston, Massachusetts, United States, 02116
United States, New York
Almirall Site #1
Brooklyn, New York, United States, 11201
Sponsors and Collaborators
Almirall, S.A.
Investigators
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Study Director: Study Director Almirall, S.A.
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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: September 13, 2022
Last Verified: September 2022
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