Lawrence Eichenfield, MD

Tolerability of Roflumilast Cream 0.05% in Infants with Eczema, With Lawrence Eichenfield, MD

Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, spoke in another segment of his 

 interview on recent long-term safety and tolerability data drawn from the INTEGUMENT-OLE study, reflecting on what roflumilast cream .05% (Zoryve) could be for toddlers and preschoolers with 

These findings were poster data presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

. Building on the efficacy findings established in the INTEGUMENT-PED pivotal trial and the phase 2 INTEGUMENT-INFANT data presented at this year's meeting, Eichenfield turned in the second part of his conversation with 

 to address these new data from INTEGUMENT-OLE.

Eichenfield was careful to distinguish between 2 related but separate concepts. Tolerability, as he framed it, is the day-to-day experience of using this topical agent, whether it burns, stings, or leads to application site reactions resulting in cessation.

Safety is the broader question of whether accumulated use over time produces immunosuppression or other systemic impacts. On both of these subjects, Eichenfield said, the INTEGUMENT-OLE open-label extension study provided reassuring answers. More than 97% of participants showed no evidence of local irritation at any assessment point across the 56-week study period.

“They also asked the caretakers about reports of stinging or burning at each visit, and it was less than 1.8% of participants at any time point who, over that 56 week time period, had problems with tolerability,” Eichenfield said.

On the safety side, treatment-emergent adverse events (AEs) taking place at rates of 4% or higher were consistent with what clinicians expect in any cohort of 2- to 5-year-olds followed over a full year. Specifically, there were upper respiratory infections at a rate of 8.7%, some nasopharyngitis, some fever, and a small number of gastrointestinal events.

Serious adverse events (AEs) were observed in 3.2% of participants, none of which were considered related to treatment. Overall, treatment-related AEs were minimal. When asked how roflumilast cream fits within the overall management landscape for this age cohort, Eichenfield acknowledged concerns over topical corticosteroids among caregivers may be higher than ever, whether or not this view is always warranted.

This creates a practical need for a non-steroidal option for families to use with confidence, Eichenfield added. He also pointed to the INTEGUMENT-INFANT data as the next frontier for this research into roflumilast, describing the evidence base as now extending to children under 2, a group where the unmet need is even more acute and where the availability of a safe, effective non-steroidal option would be especially impactful.

Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting. Arcutis. March 28, 2026. 

https://www.globenewswire.com/de/news-release/2026/03/28/3264182/0/en/Arcutis-Presents-New-Phase-2-Results-in-Infants-with-Atopic-Dermatitis-in-Late-Breaking-Session-Today-at-the-2026-American-Academy-of-Dermatology-Annual-Meeting.html

Eichenfield L. New Data Support Roflumilast Cream in Infants with Eczema Over 4 Weeks, With Lawrence Eichenfield, MD. HCPLive. March 29, 2026. Accessed March 28, 2026. 

https://www.hcplive.com/view/new-data-support-roflumilast-cream-infants-eczema-over-4-weeks-lawrence-eichenfield-md

Videos

In this segment of his interview, Eichenfield highlights the safety and tolerability of roflumilast cream for children with atopic dermatitis in INTEGUMENT-OLE.

Roflumilast Cream 0.05% Well Tolerated in Children with Eczema, With Lawrence Eichenfield, MD

Long-Term Safety of Roflumilast Cream for Children, With Lawrence Eichenfield, MD

New long-term INTEGUMENT-OLE open-label extension trial data reinforce roflumilast cream .05% (ZORYVE) as a durable, well-tolerated non-steroidal medication for children aged 2 - 5 years living with 

, with efficacy continuing to build over the full 56-week study period.

In the second half of his discussion with the team at 

, Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego, highlighted what those new results could mean in practice and their significance among this patient population.

One of the most clinically notable observations from the extension study was that efficacy did not plateau after initial response. The continued to improve over time, and Eichenfield pointed to this trajectory as a reflection of the sustained anti-inflammatory action of roflumilast as a topical PDE4 inhibitor. While the earlier 4-week INTEGUMENT-PED trial established differentiation from vehicle, this longer observation window demonstated patients who had not yet attained clear or almost-clear status at the 4-week mark continued to improve as the drug’s use continued.

Even children who had been on vehicle in the initial trial and subsequently crossed over to active treatment caught up relatively quickly, Eichenfield highlighted. Beyond direct inflammation suppression, Eichenfield also described the mechanism as working to improve patients’ skin barriers and reducing their levels of pruritus. This effectively de-amplifyies the interconnected cycle of inflammation, dysfunction of barrier, and itch representing patients’ atopic dermatitis-related burdens.

On the question of tolerability, a heightened concern given the body surface area-to-weight ratio in toddlers and preschoolers, Eichenfield characterized these new findings as reassuring. More than 97% of those evaluated showed no evidence of local irritation at any evaluation point across the 56-week period, he noted, and caregiver-reported stinging or burning was documented in fewer than 1.8% of children at any single point in time.

Additionally, Eichenfield distinguished between tolerability and safety as distinct dimensions. He described, on the safety side, treatment-emergent adverse events, such as upper respiratory infections at 8.7%, pyrexia, and nasopharyngitis, as occurring at consistent rates with what is expected in any cohort of 2- to 5-year-olds followed over a full year. Eichenfield described serious adverse events as rare, noting a lack of such events being deemed treatment-related.

Contextualizing these data within the broader management landscape, Eichenfield pointed to this age group as having had historically very few approved non-steroidal medication options, while carrying a disproportionately high disease burden. He acknowledged concerns about topical corticosteroids, whether fully warranted or not, are a real-world driver of hesitancy among caregivers. Having a therapy designed for clinicians and families to use as needed with genuine comfort, Eichenfield argued, has the potential to meaningfully shift how well atopic dermatitis is controlled early in life.

Smith T. New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children. HCPLive. March 10, 2026. Accessed March 16, 2026. 

https://www.hcplive.com/view/new-long-term-data-announced-roflumilast-cream-atopic-dermatitis-in-children

Eichenfield L. On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD. HCPLive. March 16, 2026. 

https://www.hcplive.com/view/on-new-roflumilast-cream-data-atopic-dermatitis-children-lawrence-eichenfield-md

This segment of Eichenfield's interview highlights long-term safety findings on roflumilast cream .05% for children 2 - 5 years old with atopic dermatitis.

On New Roflumilast Cream Data on Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

 interview, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego and lead author of the INTEGUMENT-OLE publication, highlighted the value of new 

 supporting roflumilast cream .05% (ZORYVE) as a sustained treatment option for young children living with atopic dermatitis.

Eichenfield opened by contextualizing the need for the open-label extension study. Although the earlier 4-week, phase 3 trial successfully demonstrated the drug’s safety and efficacy as a once-daily cream versus vehicle in children aged 2 - 5 years, Eichenfield described this short observation window as having inherent limitations, especially related to characterizing adverse events (AEs) and long-term tolerability.

In his discussion, Eichenfield underscored the unmet need for non-steroidal options in this population. Eichenfield later also noted young children with atopic dermatitis often present with high body surface area (BSA) involvement, even among those classified as mild-to-moderate, making a safe and sustained topical option especially helpful.

The INTEGUMENT-OLE trial had recruited 562 participants, all of whom had previously taken part in INTEGUMENT-PED, and treated them with once-daily roflumilast cream .05% as monotherapy. This would last for up to 52 weeks. Eichenfield highlighted the novel design element of the extension study, noting individuals attaining a complete level of skin clearance, defined as a vIGA-AD score of 0 at or after Week 4, were shifted to a proactive twice-weekly maintenance regimen.

He described this approach as generating "very interesting data" on long-term disease control, with Kaplan-Meier analysis ultimately estimating a median disease control duration of 238 days among those who entered the maintenance phase.

On the safety front, Eichenfield and colleagues found treatment-emergent adverse events in approximately half of participants, with the majority classified as mild or moderate. Serious adverse events occurred in 3.2% of children, though none were deemed treatment-related. Application-site tolerability was also favorable, with investigators reporting no signs of irritation in at least 97% of subjects throughout the study.

From an efficacy standpoint, these findings point to sustained and gradually improving responses over time. By the 56-week mark, 63.1% of those completing the extension showed a vIGA-AD score of clear or almost clear, and more than 70% across treatment arms achieved EASI-75. Eichenfield pointed to the findings as helpful within the broader context of pediatric dermatology, describing young patients as carrying a substantial disease burden while having access to relatively few approved medications.

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

Smith T. INTEGUMENT: Quality of Life with Roflumilast Cream (Zoryve) in Atopic Dermatitis. HCPLive. October 24, 2025. Accessed March 16, 2026. 

https://www.hcplive.com/view/integument-quality-of-life-roflumilast-cream-zoryve-atopic-dermatitis

This interview highlights key points regarding new data on roflumilast cream 0.05% in children aged 2 to 5 years with atopic dermatitis.

On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

What’s Next in Dermatology? Dermatologists Weigh In On 2026

 are looking ahead to a year defined by expanding oral therapeutics, immunologic insights, next-generation biologics, and the increasing artificial intelligence (AI) integration into clinical settings. At the 

 team spoke on-site with several leaders in the field of skin health about new data and therapeutic advances they anticipate shaping the field in the year ahead.

Featured leaders included Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System; Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital and professor of dermatology and pediatrics at the University of California (UC), San Diego School of Medicine; Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego; Dawn Eichenfield, MD, PhD, associate professor of dermatology and pediatrics at UC San Diego School of Medicine and Rady Children’s Hospital-San Diego; Philip J. Mease, MD, director of rheumatology research at Providence Swedish Medical Center and clinical professor at the University of Washington (UW) School of Medicine; Paul Nghiem, MD, PhD, George F. Odland Endowed Chair in Dermatology at the UW School of Medicine; and Walter J. Liszewski, MD, dermatologist and clinical educator specializing in complex medical dermatology.

Stein Gold noted 2026 may mark “the year of the oral psoriasis therapy,” highlighting anticipation surrounding the potential approval of the oral interleukin (IL)-23 inhibitor icotrokinra and continued development of next-generation TYK2 inhibitors. She pointed to the expansion of oral options as potentially providing patients with efficacy comparable to biologics without compromising safety or tolerability, broadening flexibility in systemic psoriasis.

Lawrence Eichenfield focused on atopic dermatitis, noting several unanswered questions surrounding long-term immunologic modulation. He pointed to differences among biologics targeting IL-4/IL-13 pathways, IL-13 alone, IL-31, and upstream mediators such as OX40 and OX40 ligand. Although clinical endpoints such as Eczema Area and Severity Index (EASI) scores remain central, Eichenfield indicated understanding immunologic “rebooting” after prolonged therapy may shape treatment paradigms in the future, especially among pediatric and adult patients.

Bhatia pointed to excitement around a novel systemic acne therapy, denifanstat, a fatty acid synthase inhibitor targeting de novo lipogenesis to reduce sebum production. Unlike isotretinoin or antibiotics, Bhatia describes this mechanism as addressing a key driver of the pathogenesis of acne without retinoid-associated adverse effects, representing a potential paradigm shift in moderate-to-severe acne management. It is pending additional US-based research.

Dawn Eichenfield highlighted advances in the pediatric dermatology space, particularly highlighting genetic diagnostics and evolving biologic platforms. She suggested oral biologics and medications with extended dosing intervals could improve patient adherence as well as the quality of life of children and adolescents who prefer not to experience injections at an increased frequency.

In Mease’s segment of this interview, he described continued innovation across dermatology and rheumatology, noting small-molecule and biologic therapies aimed at IL-17A/F, IL-23, and TL1A pathways. Mease additionally referenced emerging long-acting biologic options potentially requiring administration only once or twice per year. This development of emerging options reflects efforts to refine molecular configurations for sustained treatment efficacy.

Nghiem spoke in his interview about AI’s growing role in dermatology, particularly in complex malignancies such as Merkel cell carcinoma. While he acknowledged potential overhype, Nghiem emphasized AI’s potential value in expanding patient access to multidisciplinary insights and surfacing considerations clinicians may not initially identify.

In his segment, Liszewski highlighted increasing awareness of chronic hand eczema (CHE) and renewed dermatology engagement in chronic spontaneous urticaria (CSU) management, especially with the emergence of newer agents such as remibrutinib and dupilumab. These drugs, Liszewski highlighted, are reshaping treatment algorithms.

Collectively, these leading experts at Maui Derm Hawaii 2026 signaled a year defined not only by new research and emerging treatment options, but by deeper immunologic understanding, improved personalization of medications, and expanded tools to enhance patient-centered care in the field of dermatology.

For more information on research covered at the 2026 Maui Derm conference, view the full video above or check out the 

Disclosures: Stein Gold has reported serving as an investigator, advisor, or speaker for Johnson & Johnson. Lawrence Eichenfield previously reported receiving personal fees from Pfizer; grant support from AbbVie, Arcutis Biotherapeutics, Castle Biosciences, Dermavant Sciences, Galderma, Pfizer, Regeneron, and Sanofi; consulting fees from multiple pharmaceutical companies; and serving on the board of directors of Forté Pharma. Bhatia has reported serving as an advisor, consultant, and investigator for AbbVie, Almirall, Arcutis Biotherapeutics, Beiersdorf, Biofrontera, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant Sciences, EPI Health, Ferndale, Galderma, Incyte, ISDIN, Johnson & Johnson, La Roche-Posay, LEO Pharma, Lilly, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, and Verrica Pharmaceuticals. Dawn Eichenfield had no relevant disclosures of note for this interview. Mease has previously reported receiving research grants from AbbVie, Amgen, Bristol Myers Squibb, Janssen, Lilly, Novartis, Pfizer, Sun Pharma and UCB; and serving as a consultant and/or receiving speaker fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Galápagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, UCB, Ventyx Biosciences, and XinThera. Liszewski has no disclosures of note.

Stein Gold L, Hawkes J. Best of the Best at Maui Derm. Presented at the 2026 Maui Derm Hawaii Conference, January 25-29.

Eichenfield L, Silverberg J, Chovatiya R. Atopic Dermatitis and Pruritus: Current Concepts and Therapeutics for 2026. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

Rosen T, Bhatia N. New Drugs and Therapies in 2026. Presented at the 2026 Maui Derm Hawaii Conference, January 25-29.

Eichenfield D, Fallon Friedlander S, Treat J, et al. Pediatric Dermatology 2026. Presented at the 2026 Maui Derm Hawaii Conference, January 25-29.

Stein Gold L, Song E, Gordon K, et al. Psoriasis Update 2026. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

Liszewski W. Contact Dermatitis Update 2026. Presented at: Maui Derm Hawaii 2026; January 25-29, 2026; Maui, Hawaii.

Dermatology leaders preview 2026 breakthroughs including oral psoriasis drugs, new biologics, novel acne drugs, and AI tools transforming patient care.

Lawrence Eichenfield, MD

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