Investigating Roflumilast 0.05% Cream for Infant AD with Mercedes E. Gonzalez, MD

Mercedes E. Gonzalez, MD, a pediatric dermatologist based in Miami, Florida, and medical director of Pediatric Skin Research, shared insights into Arcutis’ INTEGUMENT-INFANT trial, which investigates roflumilast 0.05% cream in infants with atopic dermatitis (AD). As an expert in pediatric dermatology and investigator of the study, Gonzalez highlighted the significance of this study in addressing a critical treatment gap in infants aged 3 to 24 months, a group where AD often first presents and where FDA-approved non-steroidal treatment options remain extremely limited.

According to Gonzalez, the majority of AD cases begin within the first year of life, with up to 90% of patients showing symptoms before the age of 5. Current treatment options for this young population are predominantly limited to topical corticosteroids. The INTEGUMENT-INFANT trial aims to evaluate the safety, efficacy, and tolerability of a non-steroidal roflumilast cream, potentially offering a novel therapeutic pathway for early intervention. This early intervention could not only improve immediate symptom control but may also play a role in preventing the atopic march, which includes the later development of asthma, allergic rhinitis, and food allergies.

Gonzalez contrasted the INTEGUMENT-INFANT study with Arcutis’ earlier MUSE study, which was a pharmacokinetic trial designed to determine appropriate dosing and absorption levels for roflumilast in younger populations. Findings from MUSE helped establish the 0.05% concentration used in the current trial. She emphasized that a key advantage of the INTEGUMENT-INFANT trial is its family-friendly design. It requires no blood draws and does not include a placebo group, so all enrolled patients receive active treatment. While some families may initially hesitate to enroll their infants in a clinical trial, many are ultimately motivated by the opportunity to contribute to the development of safer, more effective therapies for pediatric AD.

“There's a large unmet need for non-steroid topical treatments in this population. So that's where roflumilast 0.05% cream would fit in very nicely as something that can not only treat the signs and symptoms of eczema in young infants, but also perhaps induce barrier repair, prolonged remissions, and adequate disease control. We're very much looking forward to it,” Gonzalez said.