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Difamilast ointment in adult patients with atopic dermatitis: A phase 3 randomized double-blind vehicle-controlled trial

Journal of the American Academy of Dermatology Oct 28, 2021

Saeki H, Ito K, Yokota D, et al. - Among Japanese adult atopic dermatitis (AD) patients, superior efficacy of difamilast 1% (a selective phosphodiesterase 4 inhibitor) ointment than vehicle as well as its favorable safety was evident.

  • A phase 3, randomized, double-blind trial of AD patients (15-70 years) with an Investigator Global Assessment (IGA) score of 2/3, who were treated with topical difamilast 1% (n = 182) ointment or vehicle (n = 182) twice daily for 4 weeks.

  • Difamilast 1% provided significantly higher success rate in IGA score at week 4 (primary endpoint) as well as in ≥ 50%, ≥ 75%, and ≥ 90% improvement in overall Eczema Area and Severity Index (EASI) score at week 4, vs vehicle.

  • From week 1 to week 4, significant mean percent improvement from baseline in overall EASI score was achieved with difamilast 1% vs vehicle.

  • Difamilast led to less frequent treatment-emergent adverse events, which were mostly mild or moderate.

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