Open-label trial: crisaborole is "well tolerated" in infants with atopic dermatitis

  • Schlessinger J & al.
  • Am J Clin Dermatol
  • 24 Mar 2020

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • 16.1% of infants with mild to moderate atopic dermatitis treated with crisaborole ointment 2% experienced treatment-related, treatment-emergent adverse events (TEAEs), according to the phase 4 open-label trial CrisADe CARE 1.

Why this matters

  • There are few approved treatment options for infants with atopic dermatitis.

Key results

  • 64.2% of patients experienced TEAEs.
    • 98.9% of TEAEs were rated as mild or moderate.
  • TEAEs were considered treatment related for 16.1% of patients.
    • The most frequently reported TEAEs were application site pain (3.6%), application site discomfort (2.9%), and erythema (2.9%).
  • 30.2% of patients achieved Investigator’s Static Global Assessment (ISGA) of clear/almost clear with ≥2 grade improvement at day 29.

Study design

  • 137 infants (aged 3 to
  • Funding: Pfizer Inc.

Limitations

  • Open-label design.