Comparison of investigator global assessment (IGA) and patient's global assessment (ptGA) of acne vulgaris among patients with moderate-to-severe non-nodular acne vulgaris (AV) administered sarecycline in community practices across the US: Analysis of PROSES study results
Recommended Citation
Stein Gold L, Alexis AF, Harper JC, Graber E, Baldwin H, Kircik L, Del R, Fried RG, Rieder EA, Hebert A, Narayanan S, Koscielny V, and Kasujee I. Comparison of investigator global assessment (IGA) and patient's global assessment (ptGA) of acne vulgaris among patients with moderate-to-severe non-nodular acne vulgaris (AV) administered sarecycline in community practices across the US: Analysis of PROSES study results. J Clin Aesthet Dermatol 2023; 16(4):S5-S6.
Document Type
Conference Proceeding
Publication Date
4-1-2023
Publication Title
J Clin Aesthet Dermatol
Abstract
Background: The objective of this analysis was to compare facial IGA and patient's Global assessment (ptGA) of AV at baseline and Weeks 4, 8 and 12, among AV patients administered sarecycline in community practices across the US.
Methods: A single-arm, prospective cohort study (PROSES) was conducted with moderateto- severe non-nodular AV patients older than 9 years who were prescribed sarecycline in realworld community practices in the US Facial IGA of patient's AV status was reported by the study clinician and ptGA of AV was collected as part of validated ASIS questionnaire; both measures used a five-point adjectival response scale of 0 (clear), 1 (almost-clear), 2 (mild), 3 (moderate), 4 (severe), and collected at baseline and Weeks 4, 8 and 12. Proportion of patients with clear/almost clear AV per IGA and ptGA were analyzed for all study timepoints.
Results: A total of 253 AV patients completed the study (adults 60.08%; pediatric 39.92%; female: 66.40%; Caucasian/white: 68.38%, African-American: 8.70%; Other-races: 22.92%; moderate AV: 86.56%; severe AV: 13.44%). At baseline, 0 percent and 4.74 percent were clear/ almost clear, per IGA and ptGA respectively. At Week-4, 9.09 percent and 29.18 percent were clear/almost-clear, per IGA and ptGA respectively. At Week-8, 33.99 percent and 41.84 percent were clear/almost-clear, per IGA and ptGA respectively. At Week-12, 58.89 percent and 59.29 percent were clear/almost-clear, per IGA and ptGA respectively. Increase in proportion of patients with clear/almost clear over time, as measured by IGA and ptGA were respectively statistically significant at p<0.0001.
Conclusion: Within the study cohort administered sarecycline, a narrow-spectrum, tetracyclinederived antibiotic, for 12 weeks, proportion of patients with clear/almost clear facial AV (as measured by clinicians and patients respectively) increased significantly, with almost six out of 10 patients achieving clear/almost clear facial AV at Week 12.
Volume
16
Issue
4
First Page
S5
Last Page
S6
