Acne Vulgaris
Conditions
Keywords
Prospective, Non-nodular Acne Vulgaris, Perceptions, Health-Related Quality of Life (HRQoL), Patient-Reported Outcomes (PROs), Signs & Symptoms
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.
Interventions
DRUGSarecycline
Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.
Sponsors
Almirall, S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the survey at 30 investigative sites from 09 March 2021 to 04 May 2022.
Pre-assignment details
A total of 300 Acne Vulgaris (AV) participants were enrolled and received treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Due to Lack of Effectiveness | 1 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Voluntary Withdrawal | 20 |
Baseline characteristics
| Characteristic | Sarecycline |
|---|---|
| Age, Categorical <=18 years | 116 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 184 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic, Latino, or of Spanish Origin | 101 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 199 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 17 Participants |
| Race/Ethnicity, Customized Race Black or African American | 32 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Race Other | 41 Participants |
| Race/Ethnicity, Customized Race Prefer not to answer | 9 Participants |
| Race/Ethnicity, Customized Race White | 195 Participants |
| Sex: Female, Male Female | 201 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 30 / 300 |
| serious Total, serious adverse events | 1 / 300 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Impact Domain Score: Baseline | 2.06 Score on a Scale | Standard Deviation 0.91 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Emotional Impact Domain Score: Baseline | 2.43 Score on a Scale | Standard Deviation 0.96 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Emotional Impact Domain Score: Change at Week 12 | -1.15 Score on a Scale | Standard Deviation 1.12 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Social Impact Domain Score: Baseline | 0.98 Score on a Scale | Standard Deviation 0.99 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Signs Domain Score: Baseline | 1.96 Score on a Scale | Standard Deviation 0.58 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Signs Domain Score: Change at Week 12 | -0.77 Score on a Scale | Standard Deviation 0.67 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Impact Domain Score: Change at Week 12 | -1.01 Score on a Scale | Standard Deviation 1.03 |
| Sarecycline | Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12 | Social Impact Domain Score: Change at Week 12 | -0.60 Score on a Scale | Standard Deviation 1.06 |
Comparison: Week 12 vs Baselinep-value: <0.0001t-test, 2 sided
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.
Time frame: At Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sarecycline | Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 | 58.89 Percentage of Participants |