Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis

J Am Acad Dermatol. 2017 Oct;77(4):641-649.e5. doi: 10.1016/j.jaad.2017.06.010. Epub 2017 Aug 18.


Background: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease.

Objective: To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302).

Methods: Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed.

Results: During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs.

Limitations: Long-term efficacy was not analyzed.

Conclusion: Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.

Keywords: PDE4; atopic dermatitis; crisaborole; eczema; long-term safety; ointment; phosphodiesterase-4; topical treatment.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Boron Compounds / adverse effects*
  • Bridged Bicyclo Compounds, Heterocyclic / adverse effects*
  • Child
  • Child, Preschool
  • Dermatitis, Atopic / chemically induced
  • Dermatitis, Atopic / drug therapy*
  • Dermatologic Agents / adverse effects*
  • Disease Progression
  • Female
  • Humans
  • Infections / chemically induced
  • Male
  • Middle Aged
  • Ointments
  • Pain / chemically induced
  • Phosphodiesterase 4 Inhibitors / adverse effects
  • Severity of Illness Index
  • Symptom Flare Up
  • Young Adult


  • Boron Compounds
  • Bridged Bicyclo Compounds, Heterocyclic
  • Dermatologic Agents
  • Ointments
  • Phosphodiesterase 4 Inhibitors
  • crisaborole