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In a recent study, crisaborole -- already approved by the FDA for the treatment of atopic dermatitis (AD) -- significantly improved signs and symptoms of stasis dermatitis (SD).

The results first appeared in the .

The randomized, double-blind, vehicle-controlled study ultimately included 65 people with SD ages 45 years or older. They were randomized to receive either crisaborole or vehicle twice daily for 6 weeks.

Patients treated with crisaborole saw greater reductions in severity scores compared with vehicle. The study team identified and evaluated the reductions using a combination of in-person assessments by non-dermatologists (-32.4% reduction for crisaborole vs -18.1% for vehicle, P=.0299) and subsequent dermatologist assessment of photographs (-52.5% vs -10.3%, P=.0004) to identify and evaluate the reduction. Improvements based on global assessment scores and lesional percentage body surface area both reached statistical significance based on dermatologist assessments but not in-person evaluations.

Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at The George Washington University School of Medicine and Health Sciences in Washington, DC, served as the current paper's first author. Here, Silverberg discusses study findings with the Reading Room. The exchange has been edited for length and clarity.

What was the initial impetus for this investigation?

Silverberg: Crisaborole is FDA-approved for the treatment of mild-to-moderate AD in patients down to age 6 months. Based on the mechanism, we would expect it to be effective potentially in not just AD but in other chronic inflammatory skin diseases.

We investigated the efficacy and safety of crisaborole in adults with SD who had no active skin ulceration.

The study had an unconventional design that was notable in and of itself. Would you explain that approach?

Silverberg: Recognizing that many patients with SD are going to be older, it may be challenging for them to come into the office frequently. This is particularly true for patients who live in rural areas or areas that are not as close to the dermatologist as others.

With that in mind, we built this study to have a decentralized approach, where there were three in-home visits and then six different telemedicine interactions.

Patients were assessed at home by a trained study investigator. In addition, we used standardized digital photography to capture images that were then evaluated in a blinded fashion by a team of dermatologists with expertise in SD to assess potential change in severity over time.

What were your key findings?

Silverberg: Crisaborole led to statistically significant improvements in SD compared to vehicle across multiple different endpoints looking at lesional severity.

Additionally, the safety profile looked very good for crisaborole versus the vehicle. In fact, adverse event rates were lower in the crisaborole arm compared to the vehicle arm. No new safety signals were observed and crisaborole was very well tolerated in the SD patients.

Do you have any recommendations or advice for clinicians based on these results?

Silverberg: First, I think the data suggest that SD may be a new indication for crisaborole in clinical practice. Obviously, it is not yet approved for that indication and more studies would be needed.

There is a big unmet need for non-steroidal treatment options for SD. These data look very promising; crisaborole could be an important addition to our toolbox for SD patients.

Given that crisaborole is not a steroid and has no limitations in terms of duration or quantities of use, and given that it was safe and well tolerated, I think this is something we can be very comfortable recommending to patients, potentially even now, albeit off-label, for the management of chronic SD.