A Phase 3 clinical trial is underway to assess the topical treatment cream roflumilast for children age 2 and 5 years old with mild-to-moderate atopic dermatitis (eczema). A previous Phase 2 trial showed supportive results for adult patients that you can read about here.
Roflumilast is not a steriod and is deemed safe and tolerable for ongoing use. Roflumilast increases the production of pro-inflammatory mediators that implicates a wide range of inflammatory diseases such as psoriasis, eczema, and COPD.
Atopic dermatitis is a long-term type of inflammation of the skin (usually on the face, inside elbows or behind knees) that results in itchy, red, irritated skin that can crack and weep. It is a severe form of eczema, and falls under the category of atopic which means it is associated with an allergic reaction. Atopic dermatitis is not contagious. Usually a dermatologist or an allergist will diagnose and treat the condition.
According to the National Eczema Association, atopic dermatitis (AD) is the most common type of eczema, affecting more than 9.6 million children and about 16.5 million adults in the United States. It’s a chronic condition that can come and go for years or throughout life, and can overlap with other types of eczema.
The trial consists of 650 people in a randomized 2:1 using the roflumilast cream 0.05% or matching vehicle cream. Arcutis Biotherapeutics anticipates topline data from INTEGUMENT-PED in late 2022.
If approved, this may be a game changer because it is nonsteroidal and not sticky. Roflumilast cream may be another helpful treatment option to children with persistent itching and provide parents with more options to help them live a better life.