Arcutis Biotherapeutics has initiated a Phase 2 trial, INTEGUMENT-INFANT, to assess the safety and tolerability of its investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 to 24 months with atopic dermatitis (AD). The four-week, open-label study will involve approximately 35 infants with mild to moderate AD. This research is particularly crucial because AD affects 9.6 million children in the US, with up to 60% developing symptoms in their first year, and currently, there are limited treatment options specifically approved for infants.
This trial addresses a significant unmet need in pediatric dermatology. Infantile AD can severely impact a child’s quality of life, disrupting sleep and increasing the risk of skin infections. It also places a considerable burden on families and caregivers. The development of safe and effective topical treatments is vital to manage the disease early and potentially minimize its long-term impact. This trial could pave the way for a new therapeutic option, offering an alternative or complement to existing treatments, and ultimately improving the lives of infants and their families.
INTEGUMENT-INFANT will evaluate the safety and tolerability of once-daily application of roflumilast cream 0.05% over four weeks. The study follows a previous successful trial (MUSE) which investigated the same formulation in infants aged 3 to 24 months with AD. Roflumilast is a highly potent and selective PDE4 inhibitor, a mechanism of action known to influence inflammatory processes in the skin. Currently, ZORYVE in other formulations and concentrations is approved for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis in older children and adults. A separate application for ZORYVE cream 0.05% for children aged 2 to 5 with AD is under FDA review.
The outcome of INTEGUMENT-INFANT could significantly expand the available treatment options for infants with AD. Positive safety and tolerability data would support further development and potential approval of this formulation, providing a much-needed therapy for a vulnerable population. This could also solidify Arcutis’ position as a leader in pediatric dermatology and set the stage for future research in even younger patient populations.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
