Participants
Patients were ≥9 years of age with a confirmed clinical diagnosis of facial non-nodular AV, had an Investigator’s Global Assessment (IGA) of score 3 (moderate) or 4 (severe), were deemed a potential candidate for sarecycline treatment per the clinician’s judgment, and capable of adhering to study procedures. Adult primary caregivers for patients aged <12 years were included. Patients were excluded if they had any facial dermatologic or physical condition that could interfere with AV clinical evaluations; had a history of allergy to tetracycline-class antibiotics or antibiotic-associated or pseudomembranous colitis; had a known resistance to tetracyclines; were receiving concurrent treatment with oral retinoids or penicillin; or were pregnant, lactating, or planning a pregnancy during the study period.
Treatment
Clinicians prescribed oral sarecycline (60 mg, 100 mg, or 150 mg) to all eligible patients prior to their selection into the study, as part of usual care. Appropriate dosages were determined based on clinician judgment and as per US Food and Drug Administration prescribing guidelines.25
Assessments
The primary assessment and endpoint was the EPQ reported at baseline and week 12 by patients ≥12 years and with the assistance of caregivers for those 9-11 years old. Additional assessments included parental/caregiver concerns about the child’s AV, understanding of the child’s AV-related concerns, and the child’s ability to accomplish future goals.
EPQ
The EPQ was developed for use in research studies to monitor and fully capture patient disease burden and treatment experiences, including the physical and psychosocial impact of AV. A 10-person consensus panel of dermatologists with expertise in the treatment of AV convened virtually and used a 3-step modified Delphi method to establish the questionnaire items; the panel included pediatric and skin of color specialists as well as 2 members with backgrounds in clinical psychology or psychiatry. Initially, a subgroup of panelists constructed items following a targeted literature review to identify over 50 PRO topics/items. This was reduced to 11 items considered most relevant for the assessment of AV burden.
Patients were ≥9 years of age with a confirmed clinical diagnosis of facial non-nodular AV, had an Investigator’s Global Assessment (IGA) of score 3 (moderate) or 4 (severe), were deemed a potential candidate for sarecycline treatment per the clinician’s judgment, and capable of adhering to study procedures. Adult primary caregivers for patients aged <12 years were included. Patients were excluded if they had any facial dermatologic or physical condition that could interfere with AV clinical evaluations; had a history of allergy to tetracycline-class antibiotics or antibiotic-associated or pseudomembranous colitis; had a known resistance to tetracyclines; were receiving concurrent treatment with oral retinoids or penicillin; or were pregnant, lactating, or planning a pregnancy during the study period.
Treatment
Clinicians prescribed oral sarecycline (60 mg, 100 mg, or 150 mg) to all eligible patients prior to their selection into the study, as part of usual care. Appropriate dosages were determined based on clinician judgment and as per US Food and Drug Administration prescribing guidelines.25
Assessments
The primary assessment and endpoint was the EPQ reported at baseline and week 12 by patients ≥12 years and with the assistance of caregivers for those 9-11 years old. Additional assessments included parental/caregiver concerns about the child’s AV, understanding of the child’s AV-related concerns, and the child’s ability to accomplish future goals.
EPQ
The EPQ was developed for use in research studies to monitor and fully capture patient disease burden and treatment experiences, including the physical and psychosocial impact of AV. A 10-person consensus panel of dermatologists with expertise in the treatment of AV convened virtually and used a 3-step modified Delphi method to establish the questionnaire items; the panel included pediatric and skin of color specialists as well as 2 members with backgrounds in clinical psychology or psychiatry. Initially, a subgroup of panelists constructed items following a targeted literature review to identify over 50 PRO topics/items. This was reduced to 11 items considered most relevant for the assessment of AV burden.
