For millions of families dealing with the red, itchy, and often sleepless nights caused by eczema, a new treatment option may be on the horizon for the youngest patients. At a recent virtual roundtable discussion held after the American Academy of Dermatology annual meeting, three leading dermatologists shared exciting new data on a topical medication called roflumilast (brand name Zoryve). The experts discussed how this once-daily, nonsteroidal cream could potentially be used safely and effectively in infants as young as 3 months old.

What the Expert Panel Discussed

The roundtable was moderated by Dr. Peter A. Lio, a dermatologist at Northwestern University Feinberg School of Medicine in Chicago. He was joined by Dr. Sarina B. Elmariah, from the UCSF Center for Itch and Neurosensory Disorders in San Francisco, and Dr. Jennifer Soung, a dermatologist and director of clinical research at Southern California Dermatology in Orange County. Together, they reviewed the latest research on topical roflumilast for atopic dermatitis, which is the medical name for eczema.

Roflumilast belongs to a class of drugs known as phosphodiesterase 4 (PDE4) inhibitors. This type of medication works by reducing inflammation in the skin without using steroids. The panel highlighted that this drug is already approved for other uses, but new data suggests it could be a game-changer for treating eczema in very young children.

The Current Treatment Gap for Infants and Toddlers

Dr. Lio pointed out a major challenge in pediatric dermatology: most prescription eczema treatments are only approved for children aged 2 years and older. The one exception is crisaborole (brand name Eucrisa), which is approved for children as young as 3 months. But Dr. Lio stressed that having just one nonsteroidal option for infants is not enough.

“We need more options there,” Dr. Lio said during the discussion. He explained that the new data on roflumilast shows it can be used at a lower dosing percentage for children in the 3-month age range, all the way up through adulthood. This could fill a critical gap in care for the youngest eczema patients.

What the Study Data Showed

The experts shared specific numbers from the research that highlight the drug’s potential. According to Dr. Elmariah, in children with mild to moderate eczema, the results were impressive:

• 34% of children achieved an Investigator Global Assessment (IGA) score of 0 or 1, meaning their skin was clear or almost clear, with at least a two-point improvement.
• 58% of children achieved an EASI 75, which means they saw a 75% improvement in their Eczema Area and Severity Index score.
• These results were seen after just 4 weeks of using the cream once daily.
• Dr. Elmariah noted that the numbers already looked great at the 2-week mark as well.

These statistics suggest that roflumilast works relatively quickly, which is important for families who are desperate for relief. The drug is also described as gentle and safe, with a once-daily application that makes it easier for parents to stick to a treatment routine.

Why This Matters for Families

Eczema is not just a skin condition. It can affect every part of a child’s life and the family’s daily routine. The intense itching can keep babies awake at night, which means parents are also losing sleep. Dr. Soung emphasized how difficult this can be.

“That population in particular, not only is the baby suffering, but also the family because baby’s not sleeping, parents aren’t sleeping,” Dr. Soung said. “Having a nonsteroidal option is huge. And I think that gives a lot more reassurance and peace of mind to parents.”

Dr. Elmariah echoed this sentiment. She explained that treating eczema is about the whole experience of the disease, including the emotional toll it takes on both the child and the parents. Sleep disruption alone can lead to stress, irritability, and difficulty functioning during the day. Having more topical options for this age group, she said, is “really critical.”

The Role of Steroids and the Rise of Steroid Phobia

Topical steroids have been a mainstay of eczema treatment for decades. They are effective at reducing inflammation and itching. However, many parents have developed what doctors call “corticophobia,” or a fear of using steroids on their children. This fear is often fueled by concerns about side effects such as skin thinning, stretch marks, or hormonal changes, especially with long-term use.

Dr. Lio acknowledged that steroids remain an important tool. “Steroids are still super important. Essentially, all of my patients are going to get steroids in some way, shape, or form,” he said. But he also noted that doctors want to be “good stewards” of these medications, meaning they want to use them wisely and not overuse them.

For families who are afraid of steroids, having a nonsteroidal option like roflumilast can be a lifeline. Dr. Lio explained that he often sees families who say, “I don’t want any more. I’m freaked out about this.” In those cases, being able to offer a different category of medication can open the door to effective treatment.

“To have something that we can use and say, ‘Listen, this is a different category. It might not be a right fit for everybody,’ but I love having these options because at the end of the day, every pot has a lid and our job is to find it,” Dr. Lio said.

What Experts Generally Say About PDE4 Inhibitors

Phosphodiesterase 4 (PDE4) inhibitors like roflumilast work by blocking an enzyme in the body that contributes to inflammation. This is a different mechanism than steroids, which work by suppressing the immune system more broadly. Because of this, PDE4 inhibitors are often considered safer for long-term use, especially in sensitive areas of the skin and in young children.

Dermatologists generally view these medications as a valuable addition to the treatment toolbox. They offer an alternative for patients who do not respond well to steroids, who have side effects from steroids, or whose families are simply uncomfortable using steroids. The fact that roflumilast is applied just once a day also makes it more convenient than some other treatments that require multiple applications.

Practical Takeaways for Parents

If you are a parent of a child with eczema, here are some key points to keep in mind based on this expert discussion:

• More options are coming. If approved for infants, roflumilast could give you another nonsteroidal choice for children as young as 3 months.
• Nonsteroidal treatments exist now. Crisaborole (Eucrisa) is already approved for babies 3 months and older. Ask your doctor if it might be right for your child.
• Steroids are still useful. While some parents fear them, steroids remain an effective and important treatment when used correctly under a doctor’s guidance.
• Treat the whole family. Eczema affects sleep and quality of life for everyone in the household. Finding a treatment that works can improve life for both the child and the parents.
• Talk to your dermatologist. If your child’s eczema is not well-controlled, or if you have concerns about current treatments, ask about new options and whether your child might be a candidate for a clinical trial or new therapy.

The Bottom Line

Eczema in infants and young children can be a frustrating and exhausting condition to manage. The prospect of a new, once-daily, nonsteroidal cream that works quickly and is safe for babies as young as 3 months is a promising development. While the data is still emerging and the medication is not yet approved for this age group, the expert panel expressed optimism about what it could mean for families.

As Dr. Lio summed it up, having more options allows doctors to find the right “lid for every pot.” For the millions of families struggling with pediatric eczema, that personalized approach could make all the difference.

Source: MedPage Today