Review of Sarecycline Effects on Acne Vulgaris: Results From Two Phase 3 Trials

Acne vulgaris
Acne vulgaris
Significant reduction in inflammatory lesions was seen at week 12 at 1.5 mg/kg/day of sarecycline, with statistically significant improvement seen as early as week 3.

The clinical efficacy of sarecycline in reducing inflammatory lesions in acne vulgaris is supported by medication review results published in Future Microbiology. Data were extracted from two phase 3 studies, SC1401 and SC1402.

SC1401 and SC1402 were identically designed, multicenter, placebo-controlled studies that examined the efficacy of sarecycline at 1.5 mg/kg on acne vulgaris. A total of 2002 patients aged 9 to 45 years with moderate to severe acne vulgaris were randomly assigned 1:1 to 12 weeks of either placebo or sarecycline 1.5 mg/kg/day. Lesion counts and Investigator’s Global Assessment (IGA) analysis were performed at week 12; IGA success was defined as having both a ≥2-point improvement from baseline IGA and a score of 0 or 1 at week 12. As secondary end points, reduction of facial inflammatory lesions were evaluated at weeks 3, 6, and 9, as well as chest, neck, and back acne.

In both trials, IGA success rate was significantly greater in the sarecycline group compared with the placebo group. At week 12 in the SC1401 study, 21.9% of the sarecycline group vs 10.5% of the placebo group achieved IGA success (P <.0001). In SC1402, 22.6% of the sarecycline group vs 15.3% of the placebo group achieved IGA success at week 12 (P <.0038). In both trials, inflammatory lesion reduction for face, chest, and trunk was significantly greater in the sarecycline vs placebo group at all time points. In terms of treatment-emergent adverse events, a slight increase in vulvovaginal candidiasis, vulvovaginal mycotic infections, nausea, and sunburn was observed in the sarecycline vs placebo group. However, no increase in rates of vomiting, diarrhea, esophagitis, dizziness, tinnitus, vertigo, or pseudotumor cerebri were noted with sarecycline.

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These data indicate that sarecycline may offer certain advantages over other treatment modalities in reducing acne vulgaris lesions. Specifically, the “narrow antibacterial spectrum [of sarecycline] may…reduce adverse effects such as diarrhea or vulvovaginal candidiasis” compared with medications such as doxycycline and minocycline, which exhibit a broader spectrum of antibacterial activity. Compared with older tetracycline-class antibiotics, sarecycline also displayed no evidence of tooth-staining in children. Thus, sarecycline has been endorsed by the US Food and Drug Administration as acne treatment in patients age ≥9 years. Based on the results of this review, investigators summarized sarecycline as having “potent Gram-positive activity,” strong anti-inflammatory effects, and a less severe adverse event profile compared with similar acne treatment modalities.

Disclosure: One study author declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Moore AY, Charles JEM, Moore S. Sarecycline: a narrow spectrum tetracycline for the treatment of moderate-to-severe acne vulgaris [published online September 2, 2019]. Future Microbiol. doi:10.2217/fmb-2019-0199