FDA Expands Pediatric Roflumilast Use - Scorecard - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

FDA Expands Pediatric Roflumilast Use

The expanded indication is supported by pharmacokinetic, safety, tolerability, exploratory efficacy, and long-term safety data from studies in children aged 2 to 5 years.

  • By

  • Kathryn Wighton

  • June 30, 2026

  • 3 min

Share

Clinical Scorecard: FDA Expands Pediatric Roflumilast Use

At a Glance

CategoryDetail
ConditionPlaque Psoriasis
Key MechanismsTopical phosphodiesterase type 4 inhibitor
Target PopulationPediatric patients aged 2 years and older
Care SettingDermatology

Key Highlights

  • Roflumilast cream 0.3% approved for pediatric use in plaque psoriasis.
  • Previously approved for adults and children aged 6 years and older at a 0.15% dose.
  • Approval based on pharmacokinetics, safety, and efficacy data from pediatric studies.
  • Topical steroids not recommended for sensitive areas or long-term use in children.

Guideline-Based Recommendations

Diagnosis

  • Diagnosis of plaque psoriasis in pediatric patients aged 2 years and older.

Management

  • Use roflumilast cream 0.3% as a topical treatment for plaque psoriasis.

Monitoring & Follow-up

  • Monitor for common adverse reactions including diarrhea, headache, and application-site pain.

Risks

  • Contraindicated in patients with moderate to severe liver impairment.

Patient & Prescribing Data

Pediatric patients aged 2 years and older with plaque psoriasis.

Roflumilast cream 0.3% is safe and well tolerated in children.

Clinical Best Practices

    Related Resources & Content

    Original Source(s)

    FDA Expands Pediatric Roflumilast Use

    • by Kathryn Wighton

    • June 30, 2026

    Related Content

    CURE: a phase-based therapeutic framework for chronic inflammation

    Mental Health May Impact Dermatologic Quality of Life

    Poorer dermatology-related quality of life was associated with greater mental health issues, while habitual probiotic intake showed no measurable relationship with these outcomes.

    Calcium signaling in psoriasis: from pathogenesis to therapeutic opportunities