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Content Update

Feb. 19, 2019

Sarecycline (Seysara) Approved for Treatment of Acne Vulgaris: In October 2018, the FDA approved sarecycline (Seysara), a once-daily oral tablet for treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in persons aged 9 years and older. Sarecycline is a tetracycline derivative with a narrower spectrum of activity than other tetracyclines, which may result in lower rates of bacterial resistance. Safety and efficacy of sarecycline were shown to be superior to placebo in two identical phase 3 clinical trials lasting 12 weeks. Adverse event rates were similar in nature to other tetracyclines and occurred at low rates. The high cost of the proprietary product may present a barrier to its adoption by health system formularies and widespread use by clinicians. Further research into the potential for reduced antimicrobial resistance is warranted.


For the chapter in the Wells Handbook, please go to Chapter 15. Acne Vulgaris.



  • image Acne is a highly prevalent disorder affecting many adolescents and adults.

  • image The etiology of this complex disease originates from multiple causative and contributory factors. The diagnosis is based on the patient’s history and clinical presentation.

  • image Elements of pathogenesis involve defects in epidermal keratinization, androgen secretion, sebaceous function, bacterial growth, inflammation, and immunity.

  • image Acne vulgaris is a chronic disorder which cannot be “cured.” Goals of treatment and prevention include control and alleviation of symptoms by reducing the number and severity of lesions, slowing progression, limiting disease duration and recurrence, prevention of long-term disfigurement associated with scarring and hyperpigmentation and avoidance of psychologic suffering. Targeting goals may increase patient adherence to therapy.

  • image The most critical target for treatment is the microcomedone. Minimizing or reversing follicular occlusion will arrest the pathogenic acne cascade and involves combining treatment measures to target all pathogenic elements.

  • image Nondrug measures are aimed at long-term prevention and treatment. Patients should eliminate aggravating factors, maintain a balanced, low-glycemic load diet, and control stress. Cleanse twice daily with mild soap or soapless cleanser, and use only oil-free cosmetics. Comedone extraction in approximately 10% of patients produces immediate cosmetic improvement. Shave infrequently as possible, using a sharp blade or electric razor.

  • image First-, second-, and third-line therapies should be appropriate for the severity and staging of the clinical presentation and directed toward control and prevention.

  • image Treatment regimens should be tapered over time, adjusting to response. Combine the smallest number of agents at the lowest possible dosages to ensure efficacy, safety, avoidance of resistance, and patient adherence.

  • image Once control is achieved, maintenance regimens should be simplified to continue with some suppressive therapy. Therapy must be continued beyond 8 weeks: efficacy is assessed through comedonal and inflammatory lesion (IL) count, control or progression of severity, and management of associated anxiety or depression. Safety end points include monitoring for treatment adverse effects.

  • image Motivate the patient to continue long-term therapy through empathic and informative ...

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