Adelaide A. Hebert, MD

Adelaide Hebert, MD, a professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston, spoke in a 

 about her team’s positive findings on the safety of roflumilast cream 0.05% (Zoryve) in younger patients with atopic dermatitis.

This phase 2 trial program, known as INTEGUMENT-INFANT, was highlighted in a poster during the 

Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference

 in Las Vegas. After having discussed the main findings, Hebert was asked in this segment of her interview about unmet needs in younger patients living with atopic dermatitis.

Implications of Findings on Roflumilast Cream 0.05% for Atopic Dermatitis, with Adelaide Hebert, MD

“What's critically important is we have very few therapeutic options that are available and FDA-approved as young as 3 months of age,” Hebert said. “...We also have some drugs that start at 2 years of age, but knowing that eczema often starts at 3 months of age, we've had an unbelievable gap in therapeutic options. We do have one biologic agent that is FDA-approved down to 6 months of age, and that has helped tremendously. But children are adverse to shots. Some parents don't want their children to undergo a shot, even though it's usually only a once-a-month dosing. So we really are extremely limited with efficacious and safe medicines in the group under 2 years of age. We now hope to bring forward a medication that absolutely will be able to achieve the successful landmarks that the FDA requires.”

Hebert noted that access to a once-daily topical option such as roflumilast cream 0.05% for atopic dermatitis in younger patients who are often averse to injections would be a significant shift in the treatment armamentarium. She was also asked about assessments of symptoms such as itch among patients as young as 3 months of age.

“Certainly, we clearly have to rely on the patients’ parents and guardians to give us the feedback regarding the child's itching,” Hebert said. “We can also look for excoriation, so we can see the telltale signs if the patient is still experiencing itching. Remember that our very, very youngest cohort patient doesn't have the neuromuscular development to do what you and I would do if we had itching…But generally, parents can relay that the total experience is. The sleeping is better, the outlook of the child is better, the total arena for the child is better.”

Hebert later noted that she hopes this data is presented to the US Food and Drug Administration (FDA) and leads to an approval of roflumilast cream 0.05% for atopic dermatitis in young patients.

“But of course, it's up to the FDA, and we respect their input and feedback regarding the clinical trial,” Hebert explained. “Then of course, we are just working on a clinical trial that goes down to 3 months of age. We're very excited to then go forward with data that will enrich the whole profile and capability of Zoryve in the realm of atopic dermatitis, even to the very youngest patients that really warrant and deserve therapy as well. The once-daily therapeutic option with a steroid-free product that has an excellent vehicle, I think, is going to be extremely rewarding for patients, parents, and, of course, the physicians who provide the care.”

For further information on roflumilast cream and its use in this younger patient population, view Hebert’s full interview video above. To find out more from DERM 2025, view our 

The quotes used in this video summary were edited for clarity.

Hebert has received research grants paid to UTHealth McGovern Medical School-Houston from Arcutis, Brickell Biotech, Dermavant, Galderma, LEO Pharma, Lilly, Mayne Pharma, Ortho Dermatologics, and Pfizer. She has received honoraria from Almirall, Arcutis, Bristol-Myers Squibb, Dermavant, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Mayne Pharma, Ortho Dermatologics, Pfizer, Verrica, and Novan Therapeutics and she serves on data safety monitoring boards for Bausch, GSK, Regeneron, and Sanofi.

Hebert A. Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD. HCPLive. August 1, 2025. 

https://www.hcplive.com/view/safety-roflumilast-cream-0-05-infants-toddlers-atopic-dermatitis-adelaide-hebert-md

Hebert A, Eichenfield L, Burnett P, et al. INTEGUMENT-INFANT: A Phase 2, 4-Week Open-Label Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less than 2 Years Old With Mild-to-Moderate Atopic Dermatitis. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 - 26, 2025; Las Vegas, Nevada.

Videos

This segment of Hebert’s DERM 2025 interview highlights additional conclusions from her team’s data on roflumilast in atopic dermatitis among infants and toddlers.

Roflumilast cream 0.05% (Zoryve) is safe as a treatment for patients aged 2 to 5 years with 

, new phase 2 findings from the INTEGUMENT-INFANT trial program suggest.

These data were presented in a poster during the 

. Adelaide Hebert, MD—professor and director of pediatric dermatology with McGovern Medical School at UTHealth Houston—spoke with 

 about the study as well as a new study for patients in this age cohort with atopic dermatitis.

Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD

“We felt it was critical to include this younger cohort of patients in a special study to better understand their response to roflumilast, and this particular concentration is a bit lower,” Hebert explained. “It's 0.05% and we know that the skin in an atopic patient is often compromised. The barrier is not as intact as normal skin….It was a four-week study. The patients received the medicine application once daily. There were certain criteria for the patients to be enrolled. They had to have mild to moderate atopic dermatitis, and they were required to have at least 3% body surface area. Patients were not enrolled if they had active infection or if they had another chronic condition, which might have prohibited us from adequately assessing the status of their atopic dermatitis.”

Hebert highlighted that during the course of the study, the patients were enrolled and roflumilast cream 0.05% was provided to the patients aged 3 months to 2 years. Both their progress in terms of atopic dermatitis and any adverse events were recorded by Hebert and coauthors.

Hebert et al’s analysis focused on such endpoints as IGA success as well as percent change from baseline in Eczema Area and Severity Index (EASI), Worst Itch-Numeric Rating Scale (WI-NRS), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI).

 They also looked at sleep disturbances and Caregiver Global Assessment (CGA) results after using roflumilast cream 0.05%. The aim of the INTEGUMENT-INFANT study is to add to results of roflumilast cream 0.05% which was studied in children ages 2 to 5 years.

“One of the things that was determined in that clinical trial was that the outcome was favorable, and that was, of course, what we anticipated, given that we had such good data on older patients in 4-week studies,” Hebert said. “The delta in terms of placebo versus active drug in our older patients was significant, and it was early in onset. So again, we felt very confident using this lower concentration in our younger cohorts, with the expected outcome that we would see positive results. That is indeed what we were able to achieve during this particular clinical trial.”

To find out any further information about roflumilast cream’s use in this population with atopic dermatitis, view Hebert’s full interview video above. For more from DERM 2025, including research on atopic dermatitis therapies, view the 

The quotes implemented in this interview summary were edited for clarity.

Hebert A, Eichenfield L, Gonzalez M, et al. INTEGUMENT-INFANT: 4-week open-label safety of roflumilast cream 0.05% in 3-24-month-olds with atopic dermatitis. Poster presented at: The Society for Pediatric Dermatology Meeting 2025. July 23-26, 2025. Seattle, Washington. Accessed August 1, 2025.

In a DERM 2025 conference interview, Hebert highlights takeaways from her team’s findings on roflumilast cream in patients aged 3 months to 2 years with atopic dermatitis.

Safety Profile, Accessibility of Tapinarof Cream for Atopic Dermatitis, with Adelaide Hebert, MD

December 2024 US Food and Drug Administration (FDA) approval

 announced by Organon for tapinarof (Vtama) cream 1% expanded the drug’s indicated age range, with patients diagnosed with atopic dermatitis aged 2 years and older now approved to receive the medication.

, the FDA approval of this aryl hydrocarbon receptor agonist and the ADORING phase 3 clinical trial program leading to the approval were discussed between the 

 editorial team and ADORING investigator Adelaide A. Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston. In the above segment of her interview, Hebert was asked about the drug’s safety profile in her team’s findings.

“We had excellent results with long term safety,” Hebert explained. “We did not see new emergent adverse events in the long term safety study that would have suggested application over that duration, up to a full 52 weeks in a full year of treatment…[would] lead to any undue sequelae. It didn't raise any concerns and we didn't see anything we call a signal, which is something we would want to identify, and it remains one of the purposes of these long term safety evaluations.”

Overall, Hebert highlighted that in the ADORING trial, tapinarof cream 1% was well-tolerated among study subjects.

“One thing we learned in addition was many of the patients can develop time off medication because of the remitive effect of this drug,” Hebert said. “And the duration of that time off drug with disease control was as much as 80 days. That is really a remarkable interval of treatment-free time when you have a condition that's chronic, relapsing, and prone to flares. So this, again, was a very important learning arena for us, as we did this clinical trial out to the 52 week time point.”

Hebert highlighted that the ADORING investigators were pleased that the patients could go without medication during this brief period. Then, she was asked about any potential barriers to accessibility to this medication for patients aged 2 years and older with atopic dermatitis.

“I think 1 of the things for those of us, particularly in the pediatric realm, is to begin to generate awareness in our colleagues within pediatrics and family practice,” Hebert said. “Because they may or may not have heard of this drug, as it was only approved previously for those patients 18 above with psoriasis, so they will have had little opportunity to see patients who are on the drug, or to have prescribed it potentially themselves. We need to educate these colleagues, because it is once-a-day, it is steroid-free, and it can be used as a single drug over all body parts. I don't think many of our pediatric colleagues are aware of what we call this remitive effect.”

To find out more information about tapinarof 1% and its safety profile among patients aged 2 years and older with atopic dermatitis, view the full video posted above.

The quotes used in this summary were edited for the purposes of clarity.

Hebert's disclosures are as follows: Research grants paid to the medical school (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte), Honoraria (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte, Sun Pharma, Ortho Dermatology, Apogee), DSMB (Sanofi Regeneron, OrthoDermatologics, GSK, Apogee).

FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. December 16, 2024. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.

Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. November 5, 2024. https://www.organon.com/news/update-on-fda-review-of-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.

This segment of Hebert’s interview features a discussion regarding the safety profile of tapinarof 1% for patients aged 2 years and older with atopic dermatitis.

Safety Profile, Accessibility of Tapinarof Cream 1% for Atopic Dermatitis, with Adelaide Hebert, MD

Impact of Tapinarof Cream Approval for Atopic Dermatitis, Adelaide Hebert, MD

Few disease states have seen the same level of advancement in recent years as 

, with notable breakthroughs, such as the December 16, 2024, 

Tapinarof is an aryl hydrocarbon receptor agonist and its approval expands the range of available treatments for atopic dermatitis, 1 of the most prevalent dermatological disorders, providing a new option for patients managing this widespread condition. To discuss the approval’s significance, the 

 editorial team spoke with Adelaide A. Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston.

“One of the things I think is tremendously exciting is that tapinarof offers us a single dose strength to use either for atopic dermatitis or psoriasis across age groups,” Hebert said. “It's a 1-day application, and the drug is also steroid free, which is very appealing in this era of, unfortunately, steroid-phobia. We needed additional medications to help patients who suffer with a chronic relapsing disease, such as atopic dermatitis, but also psoriasis.”

The drug boasts prior approvals dating back to 2022 when the agent received approval for the treatment of plaque psoriasis in adults, and the latest approval for tapinarof cream indicates the agent for treatment of atopic dermatitis in patients aged 2 years and older. The FDA approval for Organon’s aryl hydrocarbon receptor agonist, which occurred more than 2 months prior to its scheduled March 12, 2025 PDUFA, was based on significant efficacy in the ADORING clinical trial program, including ADORING 3, a 48-week extension study.

In ADORING 1 and 2, tapinarof cream 1% demonstrated robust efficacy for atopic dermatitis. In ADORING 1, 45.4% of patients treated with tapinarof achieved clear (0) or almost clear (1) skin with at least a 2-grade improvement on the Validated Investigator Global Assessment for AD (vIGA-AD) scale, compared to 13.9% in the placebo group. Similarly, in ADORING 2, 46.4% of tapinarof-treated patients met these criteria versus 18.0% with placebo (

 < 0.0001 in both trials). According to a release from Organon, tapinarof cream also improved EASI 75 scores and reduced itch severity in participants aged 12 and older.

With an interest in learning more about the approval and how it impacts the landscape of disease management for the dermatological condition, our editorial team asked Herbert about some of the treatment's potential advantages.

“One of the big advantages we have with tapinarof 1% is that the percentage that has been approved for about 2 years now for psoriasis in those patients aged 18 and above is exactly the same cream, both in formulation, tube size, everything," Hebert said. "We didn't have to really reinvent this. This drug is already on the shelf. We just now have a greater expansion of its indication in both the pediatric realm and into the realm of atop a dermatitis.”

For additional information, view the full interview posted above. 

The quotes contained in this interview summary were edited for clarity.

Adelaide Hebert, MD, discusses the impact of the recent approval for tapinarof cream in the management of atopic dermatitis. 

Adelaide A. Hebert, MD

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