Phase 3 Trial Reinforces Favorability of Roflumilast Cream 0.05% for Atopic Dermatitis in Children


A supplemental New Drug Application will be submitted for roflumilast cream 0.05% for the treatment of mild to moderate atopic dermatitis in children 2 to 5 years of age.

Positive results from the phase 3 pivotal INTEGUMENT-PED trial showed that children aged 2 to 5 years with atopic dermatitis who were treated with roflumilast cream 0.05% saw significant improvements as early as week 1.

Image credit: Марина Терехова |

Image credit: Марина Терехова |

Roflumilast cream 0.05% is a once-daily, steroid-free topical cream formulated to deliver the drug without disrupting the skin barrier. The INTEGUMENT-PED trial enrolled 652 children aged 2 to 5 years with a mean body surface area (BSA) of 22% overall, and a range from 3% to 82%. The trial met its primary endpoint and all secondary endpoints.

According to the study, 25.4% of children treated with roflumilast cream 0.05% achieved Investigator Global Assessment (IGA) Success, defined as a validated IGA–Atopic Dermatitis score of clear or almost clear plus a 2-grade improvement from baseline at week 4, compared to 10.7% treated with vehicle. Significant improvements were seen as early as week 1.

“Pediatric atopic dermatitis is a chronic, recurrent inflammatory skin condition that can negatively impact the quality of life of the child and family or caregivers,” said Adelaide A. Hebert, MD, study investigator and chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston, in a press release. “Children’s skin is uniquely sensitive and finding tolerable therapy is often more challenging. Ideally, sensitive areas such as the face and eyelids need a topical treatment that minimizes stinging and burning and is suitable for long-term use.”

Atopic dermatitis is the most common type of eczema and affects approximately 9.6 million children and 16.5 million adults in the United States. It is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This produces a red, itchy rash, most frequently on the face, arms, and legs.

Significant improvements were seen across all time points including vIGA–AD success and vIGA–AD of clear and almost clear at week 1. According to the study findings, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI-75 at week 4 compared to 20.6% treated with the vehicle. Additionally, 35.3% of children treated with roflumilast cream achieved a 4-point reduction in Worst Itch Numeric Scale at week 4, compared with 18% for vehicle-treated participants.

The trial showed that the cream was very well-tolerated. The incidence of adverse events (AEs) in the study was low and the only AE occurring in 3% or more of subjects in either arm was upper respiratory tract infection. The most frequent AEs in the roflumilast arm (2% or more) included upper respiratory tract infection, pyrexia, diarrhea, and vomiting.

Of the children randomized to roflumilast cream, 93.8% completed the full 4 weeks and there were few discontinuations due to AEs (1.1% and 1.9% in the roflumilast cream and vehicle groups, respectively). Of those who completed the study, 93.4% elected to continue open-label, long-term treatment in the INTEGUMENT-OLE study.

“Roflumilast cream was formulated with the atopic dermatitis patient in mind, delivering drug without disrupting the skin barrier or the use of sensitizing excipients and irritants. The consistent safety and tolerability profile of roflumilast cream sets our next generation PDE4 inhibitor apart,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, in the press release. “In addition, roflumilast cream provided rapid improvement and control in atopic dermatitis as well as quick reduction of itch, which provides the positive feedback loop to the parent and caregiver that the treatment is working and an incentive to maintain therapy over time.”

Arcutis recently announced the submission of a supplemental New Drug Application (sNDA) to the FDA for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and children ages 6 years and older. Following its potential approval and the positive results from the INTEGUMENT-PED study, the company intends to submit an sNDA for roflumilast cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years.


Arcutis Announces Positive Results from INTEGUMENT-PED Pivotal Phase 3 Trial of Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Children Ages 2 to 5. News release. Arcutis. September 19, 2023. Accessed September 19, 2023.

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