An observational study in Acne Vulgaris, sponsored by Almirall, S.A.. Completed at 2 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Almirall, S.A. · Observational
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.
729 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.
This study's enrollment of 300 is above the median of 90 across 81 observational studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Almirall, S.A. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patient Inclusion Criteria:
Caregiver Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
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.
Also known as: Seysara®
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
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
Participants took part in the survey at 30 investigative sites from 09 March 2021 to 04 May 2022.
| Milestone | Sarecycline |
|---|---|
| Started | 300 |
| Safety analysis set | 300 |
| Full analysis set (fas) | 253 |
| Completed | 262 |
| Not completed | 38 |
| Withdrew: Adverse event | 6 |
| Withdrew: Due to lack of effectiveness | 1 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Voluntary withdrawal | 20 |
| Withdrew: Lost to follow-up | 10 |
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.
| Score on a Scale | Sarecycline |
|---|---|
| Signs Domain Score: Baseline | 1.96 ± 0.58 |
| Signs Domain Score: Change at Week 12 | -0.77 ± 0.67 |
| Impact Domain Score: Baseline | 2.06 ± 0.91 |
| Impact Domain Score: Change at Week 12 | -1.01 ± 1.03 |
| Emotional Impact Domain Score: Baseline | 2.43 ± 0.96 |
| Emotional Impact Domain Score: Change at Week 12 | -1.15 ± 1.12 |
| Social Impact Domain Score: Baseline | 0.98 ± 0.99 |
| Social Impact Domain Score: Change at Week 12 | -0.60 ± 1.06 |
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.
| Percentage of Participants | Sarecycline |
|---|---|
| Percentage of Participants With Facial Investigator Global Assesment (IGA) Success at Week 12 | 58.89 |
Collected over From start of study up to Week 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sarecycline | 0/300 (0%) | 1/300 (0.3%) | 30/300 (10%) |
| Event | Sarecycline |
|---|---|
| Idiopathic intracranial hypertensionNervous system disorders | 1/300 |
| Event | Sarecycline |
|---|---|
| NauseaGastrointestinal disorders | 4/300 |
| DizzinessNervous system disorders | 3/300 |
| HeadacheNervous system disorders | 3/300 |
| PruritusSkin and subcutaneous tissue disorders | 3/300 |
| RashSkin and subcutaneous tissue disorders | 3/300 |
| Abdominal discomfortGastrointestinal disorders | 2/300 |
| DiarrheaGastrointestinal disorders | 2/300 |
| COVID-19Infections and infestations | 2/300 |
| Vulvovaginal mycotic infectionInfections and infestations | 2/300 |
| MigraineNervous system disorders | 2/300 |
Safety population included all participants who received at least one dose of sarecycline during the study observation period, as part of usual care.
| Age, Categorical(Participants) | Sarecycline |
|---|---|
| <=18 years | 116 |
| Between 18 and 65 years | 184 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Sarecycline |
|---|---|
| Female | 201 |
| Male | 99 |
| Race/Ethnicity, Customized(Participants) | Sarecycline |
|---|---|
| Ethnicity — Hispanic, Latino, or of Spanish Origin | 101 |
| Ethnicity — Other | 199 |
| Race/Ethnicity, Customized(Participants) | Sarecycline |
|---|---|
| Race — White | 195 |
| Race — Black or African American | 32 |
| Race — American Indian or Alaska Native | 3 |
| Race — Asian | 17 |
| Race — Native Hawaiian or Other Pacific Islander | 3 |
| Race — Other | 41 |
| Race — Prefer not to answer | 9 |
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Almirall, S.A.