Sarecycline has been found to be effective in treating moderate to severe facial acne vulgaris among patients with skin of color, according to study results presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17-21, 2023, in New Orleans, Louisiana. Authors of the phase 3 research reported that improvements can be seen as early as week 3 of treatment and continues through week 12.
Investigators conducted post hoc analysis of 2 phase 3 trials (ClinicalTrials.gov Identifiers: NCT02320149 and NCT02322866) examining the treatment of facial acne vulgaris with sarecycline in 887 patients who self-identified as Black/African American, Asian, and/or Hispanic/Latino. Race and ethnicity were not mutually exclusive.
The participants received either sarecycline 1.5 mg/kg (n=445) or placebo (n=442) daily for 12 weeks. Success was measured as change from baseline to week 12 in Investigator’s Global Assessment (IGA) score and inflammatory lesion count. The IGA score needed to be 0 or 1, with at least a 2-point improvement from baseline, to be considered success.
For patients with facial acne vulgaris, sarecycline was more likely to deliver IGA success than placebo (24.5% vs 14.7% P =.0006). The difference was statistically significant among participants of Hispanic/Latino ethnicity (P =.0023). It was solely discernable among individuals who had Black/African American and Asian ethnicity.
A significant difference in inflammatory lesion count based on treatment was documented beginning at week 3 (week 3: -27.34 [2.04] vs -21.71 [2.00]; P =.01; week 12: -54.62 [2.41] vs -39.49 [2.37]; P <.0001).
Among patients with facial acne vulgaris, sarecycline helped improve lesion counts throughout the study (P <.05). Participants who were Black/African American and who received sarecycline had lower mean inflammatory counts. The decrease was significant among patients who were Asian (P =.0037) and Hispanic/Latino (P <.0001).
Adverse events were similar among the treatment groups.
Disclosure: This research was supported by Almirall. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
References:
Keri J, Harper J, Baldwin H, et al. Efficacy of sarecycline for facial acne vulgaris in patients with skin of color: post hoc analysis of phase 3 trials. Poster presented at: American Academy of Dermatology (AAD) 2023 Annual Meeting; March 17-21, 2023. Poster 43102.