Not a steroid no boxed warning
ZORYVE (roflumilast) Cream 0.05% and ZORYVE (roflumilast) Cream 0.15%
Simple once-daily treatmentSimple once-daily treatment

For age 2–5

For age 6+

Pivotal Safety

CONSISTENTLY WELL TOLERATED AND SAFE

Cream 0.15%  |  Age 6+Cream 0.05%  |  Age 2–5

Pivotal Safety

SAFE FOR ANY LOCATION1, 3

  • Low rates of stinging or
    burning (<1.0%)4*
  • Not associated with folliculitis,
    atrophy, striae, or HPA-axis
    suppression3
  • Low rate of discontinuation
    due to adverse events (1.1%)3

HPA = hypothalamic-pituitary-adrenal.

*Low rates of hot, stinging/burning sensation reported in caregiver-rated tolerability assessments 10–15 minutes after first application: 0.5% with ZORYVE (n=437) vs 2.8% with vehicle (n=214).

Open-label long-term safety study

The safety profile observed at Week 52 was generally consistent with the atopic dermatitis pivotal trials. No new safety signals were identified with ZORYVE cream 0.05%.

The long-term safety of ZORYVE cream 0.15% and ZORYVE cream 0.05% was assessed in an open-label, 52-week, extension trial of 1219 subjects 2 years of age and older with mild to moderate atopic dermatitis who had completed the 4-week INTEGUMENT-1 or -2 (aged ≥6 years), or INTEGUMENT-PED trial (aged 2–5 years).

See Efficacy Data

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