INTEGUMENT-INFANT Study to Evaluate Roflumilast in Patients Aged 3-23 Months
NASHVILLE, Tenn. – Arcutis Biotherapeutics unveiled plans for a pioneering phase 2 clinical trial evaluating roflumilast cream in infants with atopic dermatitis (AD) at the 2025 Revolutionizing Atopic Dermatitis (RAD) conference.
Addressing Critical Unmet Need
The INTEGUMENT-INFANT study will assess the safety and efficacy of roflumilast 0.05% cream in patients aged 3 months to under 2 years – a population with limited treatment options. AD incidence peaks between 3-6 months of age, yet current therapies often prove inadequate or carry safety concerns for infants.
“This trial represents an important step in addressing the therapeutic gap for our youngest AD patients,” researchers noted in their conference poster presentation.
Study Design Highlights
| Trial Feature | Details |
|---|---|
| Design | Phase 2, open-label, single-arm |
| Duration | 4 weeks treatment |
| Formulation | Roflumilast 0.05% cream (ethanol-free) |
| Application | Once daily to all affected areas including scalp |
| Patient Population | ~100 infants (3-23 months) across 25 sites |
Key Endpoints
Primary: Safety and tolerability (AEs, vital signs)
Secondary:
- vIGA-AD scores
- EASI measurements
- Scalp-specific assessments
Patient-reported:
- WSI-NRS itch scores
- IDQOL and DFI questionnaires
Scientific Rationale
The lower 0.05% concentration was selected because:
- Infants have higher body surface area to mass ratios
- Typically require treatment of larger affected areas
- Need for consistent pharmacokinetics across age groups
This builds on positive phase 3 INTEGUMENT-PED results in children aged 2-5 years.
Exclusion Criteria
The study will exclude patients with:
- Concurrent dermatologic conditions
- Active infections
- Unstable AD requiring high-potency steroids
- Undergoing food challenges/allergy testing
Potential Clinical Impact
If successful, this trial could:
- Provide first scalp-appropriate AD treatment for infants
- Offer a well-tolerated alternative to steroids
- Establish safety data for this vulnerable population
Results are expected to inform future pediatric AD treatment guidelines and potentially expand roflumilast’s approved indications.
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