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

  • Low rates of stinging or
    burning (1.6%)2*
  • Not associated with folliculitis,
    atrophy, striae, or HPA-axis
    suppression1
  • Low rate of discontinuation
    due to adverse events (1.6%)1

HPA = hypothalamic-pituitary-adrenal.

Insomnia was reported in fewer than 1% of patients treated with ZORYVE.

*Low rates of hot, tingling/stinging sensation reported in patient-rated tolerability assessments 10–15 minutes after first application: 1.6% with ZORYVE (n=883) vs 2.0% with vehicle (n=451).

†Based on pooled safety data from INTEGUMENT-1 and INTEGUMENT-2.

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 0.15%.

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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