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Nonsteroidal topicals for atopic dermatitis
Topical Therapies for Mild to Moderate Atopic Dermatitis: Personalizing Care With New and Emerging Nonsteroidal Treatment Options

Released: June 13, 2025

Expiration: June 12, 2026

Benjamin Ungar
Benjamin Ungar, MD
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Key Takeaways
  • The nonsteroidal topical therapy landscape for atopic dermatitis (AD) has increased in recent years to include 3 additional agents with excellent safety profiles and proven efficacy.
  • Despite the Black Box warning on the label for ruxolitinib cream 1.5%, 1-year postapproval data does not show that it leads to increased risk for the serious adverse events associated with oral JAK inhibitors.
  • Ruxolitinib cream 1.5%, roflumilast cream 0.15%, and tapinarof cream 1% are particularly beneficial when AD occurs on sensitive areas of the body (ie, face and intertriginous areas).

Topical corticosteroids play an important role in the treatment of mild to moderate disease in managing patients of all ages who have atopic dermatitis (AD). They are often effective and in many cases work relatively quickly. However, there are limitations with using topical corticosteroids from a practical, clinical, and patient perspective. These include safety considerations with chronic use and inappropriate potency, particularly in sensitive areas. If there is a large body surface area involved, use of these therapies can include risk of systemic absorption and adverse events (AEs). Furthermore, many patients have concerns regarding the use of steroids, whether it be steroid withdrawal syndrome or other safety-related AEs. This then creates a situation where nonsteroidal topical therapies can pose a beneficial option in the treatment of mild to moderate AD, allowing us healthcare professionals to go beyond the use of topical corticosteroids.

Nonsteroidal Topical Therapies for AD
In the recent past, there were only a few nonsteroidal options that had proven efficacy in treating AD: tacrolimus ointment 0.03% and 0.1% (patients 2-15 years of age can only use 0.03% strength), pimecrolimus cream 1%, and crisaborole ointment 2%. These topical therapies have all expanded the AD treatment landscape, but there are 3 additional nonsteroidal topical therapies that were approved more recently and offer potential to further expand the treatment landscape for mild to moderate AD. These include ruxolitinib cream 1.5%, roflumilast cream 0.15%, and tapinarof cream 1%. These “newer” nonsteroidal options are excellent considerations for treating mild to moderate disease because of their excellent safety profiles. They are generally safer to use, regardless of the anatomical location and the body areas involved.

Now there are some nuances with each specific approval that need to be addressed. For example, ruxolitinib cream 1.5% is a topical JAK inhibitor indicated for use in mild to moderate AD on up to 20% of patients’ body surface area. For patients with increased body surface area involvement, they should be considered to have more moderate to severe disease and treated as such. Then there is the potential for an increased body surface area involvement to lead to systemic absorption. For the most part, I have seen that as a very low concern with these “newer” nonsteroidal topical therapies because their safety profiles are quite favorable. Only in a small percentage of patients is there irritation or folliculitis. Additional AEs with these agents include headache, nausea/vomiting, and diarrhea, but these are not major concerns on a day-to-day basis.

Boxed Warnings and Additional Indications
It should be noted that there is a boxed warning in the labeling of ruxolitinib cream 1.5% because of the risks that are associated with the use of systemic JAK inhibitors. Although the FDA placed the same warnings on this agent as seen with oral JAK inhibitors, there were no data in a study of ruxolitinib cream 1.5% one year after FDA approval that shows that these risks are meaningfully increased. This agent received FDA approval for use in patients 12 years of age or older for short-term, noncontinuous chronic treatment. A ruxolitinib cream 1.5% benefit is that it can have a low threshold for use when there are flares, which is likely an occurrence in the course of AD.

In addition, ruxolitinib cream 1.5% is approved to treat nonsegmental vitiligo in patients 12 years of age or older. In the phase III clinical trials for vitiligo, this agent was used twice daily for several months and had low rates of serious AEs compared with vehicle cream. Although different disease states may require specific treatment-related considerations, this may be helpful information to consider when managing AD.

Regarding roflumilast cream, the 0.3% strength is indicated to treat patients 6 years of age or older with plaque psoriasis. But only the 0.15% strength is approved to treat the same age group with mild to moderate AD. It is used once daily and has a favorable safety profile. This agent should be considered for use in mild to moderate AD, particularly when addressing sensitive areas of the body like the face or intertriginous areas. In my practice, I have seen these areas of the body be susceptible to AEs with the use of topical corticosteroids, and both ruxolitinib cream 1.5% and roflumilast cream 0.15% are particularly beneficial when AD occurs on these sensitive areas. With roflumilast 0.15% cream, the most commonly reported AEs were headache, nausea, diarrhea, vomiting, and application site pain.

Most recently, tapinarof cream 1% was approved to treat AD in patients 2 years of age or older. This agent is also approved to treat adults with plaque psoriasis, but real-world data in this patient population are lacking. In general, tapinarof cream 1% is well tolerated and can be considered for use on any anatomical location. The common AE seen with this treatment is folliculitis.

Your Thoughts
How often do you prescribe nonsteroidal topical therapy in patients 12 years of age or older with mild to moderate AD? You can get involved in the discussion by answering the question and posting a comment below.

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