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

NCT04820673 | Completed Results FDA Drug

• 1 other identifier: M-24001-40
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Keywords

Prospective; Non-nodular Acne Vulgaris; Perceptions; Health-Related Quality of Life (HRQoL); Patient-Reported Outcomes (PROs); Signs & Symptoms

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12

  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 domain. The total score is the average of all 17 items. Higher scores on the ASIS Sign domain, comprised of all items that assess symptoms (items 1-9), indicate the presence of more severe symptoms, whereas higher scores on the ASIS Impact domain, comprised of all the items that assess impacts (items 10-17), indicate a greater negative impact of acne.

  Baseline, Week 12

Secondary Outcomes (1)

• Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12

  At Week 12

Study Arms (1)

Sarecycline

Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment.

Drug: Sarecycline

Interventions

Sarecycline DRUG

Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.

Also known as: Seysara®

Sarecycline

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Primary caregiver of the study-eligible patient
• Male or female, aged 18 years and above

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (2)

Almirall Site#2

Boston, Massachusetts, 02116, United States

Location

Almirall Site #1

Brooklyn, New York, 11201, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Signs and Symptoms

Interventions

sarecycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A.

rd@almirall.com

+34932913000

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: March 9, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)