Roflumilast Cream Shows Safety and Efficacy in Infants With Atopic Dermatitis

Roflumilast cream 0.05%, a topical phosphodiesterase 4 (PDE4) inhibitor, demonstrated favorable safety and clinically meaningful efficacy in infants with atopic dermatitis (AD), according to results from the Phase 2 INTEGUMENT-INFANT study presented by Lawrence F. Eichenfield, MD, at the American Academy of Dermatology (AAD) 2026 Annual Meeting.

The open-label study enrolled 101 infants aged 3 to <24 months with mild-to-moderate AD, a population with limited approved treatment options.

“We know that infantile atopic dermatitis is something that is quite common, and that in fact families experience a substantial burden from infantile atopic dermatitis, and we have limited evidence of basis for treatments for this population.,” Dr. Eichenfield said. 

Caregivers applied roflumilast cream once daily for 4 weeks. The primary endpoints focused on safety and tolerability, which were favorable. Treatment-emergent adverse events were reported in 46.6% of participants, all mild to moderate, with no serious adverse events. Application-site tolerability was notable, with no evidence of irritation in at least 97.9% of patients throughout the study.

Efficacy outcomes showed clinically meaningful improvements. At Week 4, 34.4% of patients achieved vIGA-AD success (clear/almost clear with ≥2-point improvement), while 49.0% reached vIGA-AD 0/1. EASI-75 responses were observed in 58.3% of patients. Improvements were also seen in itch, with 60.6% achieving a ≥4-point reduction in Worst Scratch/Itch Numeric Rating Scale.

Dr. Eichenfield highlighted the rapid onset of symptom relief.

“At 24 hours, there was already 10% of the population that had that 4-point drop in itch and it increased steadily over the 4-week … course up to 86.3% of patients with that 4-point drop in itch,” Dr. Eichenfield said.

Caregiver-reported improvements in pruritus were also observed within minutes of application using the Dynamic Pruritus Scale.

The formulation, designed without common irritants such as propylene glycol and alcohols, may contribute to its tolerability in this age group.

“This product was created with absence of skin-irritating excipients,” Dr. Eichenfield noted.