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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarecycline | Eligible patients prescribed with commercially available sarecycline will be followed-up for 12 weeks post-initiation of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarecycline | Drug | Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 | The investigator assessed the participant's facial acne using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). Percentage of participants who achieved facial IGA success at Week 12 were reported. |
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Inclusion Criteria:
Patient Inclusion Criteria:
Caregiver Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Site#2 | Boston | Massachusetts | 02116 | United States | ||
| Almirall Site #1 |
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A total of 300 Acne Vulgaris (AV) participants were enrolled and received treatment in this study.
Participants took part in the survey at 30 investigative sites from 09 March 2021 to 04 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sarecycline | Participants prescribed with commercially available sarecycline 1.5 milligram per kilogram per day (mg/kg/day), tablets, orally were followed for up for 12 weeks post-initiation of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least one dose of sarecycline during the study observation period, as part of usual care.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sarecycline | Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS included all participants within the safety population that had at least one question answered pertaining to study primary research objective and who completed their Week-12 survey. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 12 |
From start of study up to Week 12
Safety analysis set included all participants who started the study and received at least one dose of the sarecycline during the study observation period, as part of usual care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sarecycline | Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA (20.21) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.21) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Global Clinical Development | Almirall S.A. | +34932913000 | rd@almirall.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2021 | Jun 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2022 | Jun 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629276 | sarecycline |
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| At Week 12 |
| Brooklyn |
| New York |
| 11201 |
| United States |
| Voluntary Withdrawal |
|
| Lost to Follow-up |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Sarecycline | Participants prescribed with commercially available sarecycline 1.5 mg/kg/day, tablets, orally were followed for up for 12 weeks post-initiation of treatment. |
|
|
|
| Secondary | Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 | The investigator assessed the participant's facial acne using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). Percentage of participants who achieved facial IGA success at Week 12 were reported. | FAS included all participants within the safety population that had at least one question answered pertaining to study primary research objective and who completed their Week-12 survey. | Posted | Number | Percentage of Participants | At Week 12 |
|
|
|
| 0 |
| 300 |
| 1 |
| 300 |
| 30 |
| 300 |
| Abdominal pain (upper) | Gastrointestinal disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Injury associated with device | General disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (20.21) | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA (20.21) | Non-systematic Assessment |
|
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA (20.21) | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (20.21) | Non-systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA (20.21) | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA (20.21) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (20.21) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (20.21) | Non-systematic Assessment |
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| Migraine with aura | Nervous system disorders | MedDRA (20.21) | Non-systematic Assessment |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.21) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.21) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.21) | Non-systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |