Management of Truncal Acne With Oral Sarecycline: Pooled Results from Two Phase-3 Clinical Trials

J Drugs Dermatol. 2021 Jun 1;20(6):634-640. doi: 10.36849/JDD.2021.6204.

Abstract

Background: Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris.

Method: Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12.

Results: Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne. J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204.

Publication types

  • Clinical Trial, Phase III

MeSH terms

  • Acne Vulgaris* / diagnosis
  • Acne Vulgaris* / drug therapy
  • Anti-Bacterial Agents / adverse effects
  • Humans
  • Pharmaceutical Preparations*
  • Tetracyclines / therapeutic use*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Pharmaceutical Preparations
  • Tetracyclines
  • sarecycline