Rocco Serrao, MD, works for Dermatologists of Southwest Ohio, an affiliate practice of Dermatologists of Central States (DOCS), and as an associate clinical professor of Dermatology at Wright State University.

Discussing INTEGUMENT-INFANT and Roflumilast Cream 0.05% in Atopic Dermatitis, With Rocco Serrao, MD

The open-label, phase 2 INTEGUMENT-INFANT clinical study, assessing investigational once-daily roflumilast (Zoryve) cream 0.05%, recently completed enrollment.

The study is evaluating the safety and tolerability of investigational once-daily roflumilast (Zoryve) cream 0.05% in infants aged 3 months to less than 24 months living with 

. To discuss the significance of this analysis, 

 spoke with Rocco Serrao, MD, an associate clinical professor of Dermatology at Wright State University.

“There's such a paucity of these therapies available in the atopic space in general, but then especially in our young ones, especially our infants,” Serrao explained. “Here we're talking a population in this trial, three months of age up to two years. So, [we have] just a real lack of therapies for this population.”

Serrao noted 9.4 million children around the world suffer from the skin disease, with 60% being diagnosed before 1 year of age. Current treatments are limited, Serrao explained, with topical options such as steroids and calcineurin inhibitors often insufficient for long-term management of atopic dermatitis.

, is using endpoints such as Investigator's Global Assessment (IGA) success as well as percent change from the point of baseline in Worst Itch-Numeric Rating Scale (WI-NRS), Eczema Area and Severity Index (EASI), and Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM).

“Some parents and caregivers are hesitant to put their child on a systemic drug with maybe no end in sight,” Serrao said. “They want to try, hopefully, to avoid putting a systemic treatment in their child's body, no matter how safe it is or how safe it's perceived to be, just because they're concerned as a parent. They may want to try and avoid systemic therapy. There's a huge need for therapies that are topical to manage [atopic dermatitis].”

For additional information, view the full video interview with Serrao posted above.

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

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.

Hebert A. Safety of Roflumilast Cream 0.05% in Infants and Toddlers with Atopic Dermatitis, with Adelaide Hebert, MD. HCPLive. August 1, 2025. Accessed December 11, 2025. 

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

Articles

The INTEGUMENT-INFANT phase 2 study has completed enrollment to evaluate the safety and tolerability of roflumilast cream 0.05% in infants with mild to moderate atopic dermatitis. This demographic, aged 3 months to less than 24 months, has limited treatment options, with current therapies often inadequate for long-term management. The study uses endpoints like IGA success and changes in WI-NRS, EASI, DLQI, and POEM. Parents often prefer topical treatments over systemic ones due to safety concerns, highlighting the need for effective topical therapies.

In this interview, Serrao discusses the significance of the phase 2 INTEGUMENT-INFANT study, assessing once-daily roflumilast (Zoryve) cream 0.05% in infants with atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

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clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Review of new week 52 results showing durable responses and strong efficacy in both adults and adolescents.

Icotrokinra vs Deucravacitinib: Results from the ICONIC-ADVANCE 1 and 2 Trials 

, despite the expanding therapeutic landscape. Linda Stein Gold, MD, and her colleagues analyze patient- and provider-reported data from the 

 surveys, revealing that many patients remain dissatisfied with current therapies and that oral agents are overwhelmingly preferred over injectables. The experts discuss how patient lifestyle, comorbidities, and psychosocial burden influence shared decision-making and treatment adherence. They also interpret the 

International Psoriasis Council’s (IPC)

 and explore its implications for reducing “topical churn” and advancing systemic therapy earlier in the disease course.

 and its potential to close current gaps in care. The panel provides an in-depth review of the 

 clinical development program, summarizing the 

 trials, which demonstrated superior efficacy versus deucravacitinib at both 16 and 24 weeks, with favorable safety and tolerability. They also discuss new 

 showing sustained clearance and no new safety signals in adults and adolescents. The faculty reflect on ICO’s implications for adolescent psoriasis and how early, aggressive oral intervention may help prevent progression to psoriatic arthritis, marking a significant milestone in the evolution of oral IL-23–targeted therapy.

The final portion of the series shifts focus to 

managing active psoriatic arthritis (PsA)

. The experts discuss new findings from the 

 demonstrated the first clear evidence of IL-23–mediated inhibition of structural joint damage, reinforcing the rationale for early biologic use in high-risk patients. They compare APEX to prior IL-23 studies, discuss implications for therapy sequencing, and highlight other emerging data from 

 studies. In closing, Stein Gold and colleagues emphasize a forward-looking approach that integrates personalized therapy selection, early detection of PsA, and cross-specialty collaboration to elevate standards of psoriasis care

Videos

Video Series

Discussion of nasopharyngitis and URTI as the most common AEs and how the safety profile compares to other oral agents.

Treating High-Impact Areas in Psoriasis: Results From the ICONIC-TOTAL and SPECTREM Trials

Valeria Cohran, MD is a professor of pediatrics and the medical director of intestinal rehabilitation and transplant at Ann and Robert H Lurie Children's Hospital of Chicago.

Predicting Teduglutide Treatment Response for Pediatric SBS-IF, With Valeria Cohran, MD

New research is shedding light on the characteristics of children with short bowel syndrome-associated intestinal failure (SBS-IF) by response to teduglutide, including attainment of consistent response and sustained enteral autonomy.

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

 Annual Meeting by Valeria Cohran, MD, a professor of pediatrics and the medical director of intestinal rehabilitation and transplant at Ann and Robert H Lurie Children's Hospital of Chicago.

Teduglutide, first approved by the US Food and Drug Administration for adults with SBS in 2012, was later granted approval for pediatric patients ≥ 1 year of age with SBS who need additional nutrition or fluids from intravenous feeding in 2019. The human glucagon-like peptide-2 analog reduces PN/IV dependency in children with SBS-IF, but identifying patient characteristics that predict response to teduglutide is crucial for guiding clinical decisions.

“The reason we wanted to do this study was to evaluate the characteristics of children with short bowel syndrome and intestinal failure, and by looking at the response to teduglutide, trying to see what certain characteristics may predict who's going to be a responder to this medication,” Cohran told 

This post hoc analysis pooled data from pediatric patients who took part in 1 of 2 open-label, multicenter, phase 3, long-term extension (LTE) studies over 96 weeks and their respective parent studies. Patients were grouped by whether or not they were consistent responders, defined as ≥20% PN/IV volume reduction from baseline for ≥90 consecutive days during parent and LTE studies, and whether or not they attained sustained enteral autonomy, defined as 100% reduction from baseline in PN/IV for ≥90 consecutive days.

In total, 23 patients were consistent responders and 46 were non-consistent responders. Of the non-consistent responders, 9 had no response, 1 had a response only during a parent study, 15 had a response only during an LTE study, and 21 had a response during both parent and LTE studies for <90 days. A total of 18 patients attained sustained enteral autonomy.

For patients with data available, consistent responders were significantly older (mean age, 7.9 vs 4.4 years; 

<.001), had longer mean time since SBS diagnosis (7.1 vs 5.0 years; 

= .016), and lower mean baseline PN/IV volume (53.5 vs 70.5 mL/kg/day; 

= .030) and duration (10.7 vs 13.1 hours/day; 

Investigators noted a significantly greater proportion of consistent responders had an ileocecal valve present (30.4% vs 15.2%; 

= .047) and a lower proportion had some remaining colon than non-consistent responders (87.0% vs 100.0%; 

= .012). Patients who attained sustained enteral autonomy were significantly older (mean age, 7.1 vs 5.0 years; 

= .036), had greater mean length of remaining small intestine (57.3 vs 36.3 cm; 

= .036), and lower mean baseline PN/IV volume (48.6 vs 70.6 mL/kg/day; 

= .008) and duration (10.3 vs 12.7 hours/day; 

Univariate analyses identified older age at baseline and longer time since SBS diagnosis to be significantly associated with greater likelihood of consistent response, and older age at baseline and length of remaining small intestine to be significantly associated with greater likelihood of sustained enteral autonomy (

<.05). Of note, due to small sample sizes, multivariate analyses were not conducted.

“We need longer term studies, and as more patients are being treated with this drug, that's going to allow us to have more information about who is going to be a better responder to this agent,” Cohran said.

Editors’ Note: Cohran reports relevant disclosures with Takeda.

Cohran V, Carter B, Kocoshis S, et al. CHARACTERISTICS ASSOCIATED WITH RESPONSE TO TEDUGLUTIDE TREATMENT IN CHILDREN WITH SHORT BOWEL SYNDROME-ASSOCIATED INTESTINAL FAILURE: A POST HOC ANALYSIS OF LONG-TERM EXTENSION STUDIES. Presented at 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

Pessoa Gingerich C. FDA Approves Teduglutide for Pediatric Use. HCPLive. May 17, 2019. Accessed December 10, 2025. 

https://www.hcplive.com/view/fda-approves-teduglutide-for-pediatric-use

Recent research has explored the characteristics of pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF) in response to teduglutide treatment. The study identified factors predicting consistent response and sustained enteral autonomy, such as older age, longer time since diagnosis, and specific anatomical features. Consistent responders were generally older, had longer time since SBS diagnosis, and lower baseline PN/IV volume. The presence of an ileocecal valve and longer remaining small intestine were also significant. The study highlights the need for further research to better predict patient response to teduglutide.

Cohran describes her research on characteristics linked to treatment response to teduglutide for short bowel syndrome-associated intestinal failure.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Potential Advantages of Oral BTKi in CSU Management

The oral administration of Bruton tyrosine kinase inhibitors (BTKi) such as remibrutinib confers several advantages over injectable therapies in the treatment of chronic spontaneous urticaria (CSU). For many patients, oral therapy aligns with preferences for convenience, ease of use, and avoidance of injection-site complications. Remibrutinib's efficacy, established in phase 3 trials, offers a non-invasive alternative without compromising clinical effectiveness or safety.

Patient autonomy in selecting therapy is increasingly recognized as central to shared decision-making in chronic disease management. Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, emphasizes that many individuals with CSU prioritize not only therapeutic benefit and safety but also the practical considerations of daily administration. When clinical efficacy and safety profiles are comparable, the oral route may improve adherence and facilitate rapid symptom control, contributing to improved patient satisfaction.

Importantly, the expansion of approved therapies for CSU—from a single injectable agent to multiple options, including oral BTK inhibitors—enhances clinicians' ability to tailor management strategies to individual patient circumstances. This broadened therapeutic landscape allows for more nuanced discussions addressing each patient’s unique treatment goals, comorbidities, and lifestyle requirements, optimizing outcomes in CSU care.

Shyam Joshi, MD, highlights the practical and patient-centered advantages of oral BTK inhibitors in the management of chronic spontaneous urticaria.


Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

In a phase 3 trial, the first-in-class triple agonist delivered up to an average of 71.2 lbs weight loss and reduced WOMAC pain scores for knee osteoarthritis.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Osteoarthritis

On the HCPLive osteoarthritis page, resources on the topics of medical news and expert insight into OA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on degenerative joint disease, and more.

Rheumatology

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TRIUMPH-4: Retatrutide Delivers Weight Loss, Knee Osteoarthritis Pain Relief

Pediatrics

Pediatrics page, resources on the topics of medical news and expert insight into childhood health care can be found. Content includes articles, interviews, videos, podcasts, and breaking news on pediatric disease research, treatment, and drug development.

Infectious Disease

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on viruses, infections, and bacteria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for COVID-19, influenza, vaccine-preventable diseases, and more.

This Year In Medicine

2025: A year of fewer vaccines and increasing distrust

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Podcasts

Reau and Brown discuss the recent CDC APIC decision to remove the universal birth-dose hepatitis B vaccine for infants born to mothers who test negative for HBV.

Hepatology

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Liver Lineup: Updates & Unfiltered Insights

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

Liver Lineup: Navigating Hepatitis B Prevention After ACIP’s Birth Dose Shift

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

From diagnosis, investigators sought to explore psoriasis characteristics, patient demographics, patterns of treatment, and disease progression.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Mild to Moderate Psoriasis Linked with Indicators of Suboptimal Treatment, Disease Control

Ira Zackon, MD, is the senior medical director of Ontada Medical Office.

Zackon discusses a retrospective 20-year analysis, which implies an easier-to-achieve hemoglobin target in myelodysplastic syndrome treatment.

Hematology

Anemia

Higher Maintained Hemoglobin Associated With Improved Survival in MDS, With Ira Zackon, MD

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A study shows that knowledge of hyperuricemia alone doesn’t drive practice. Attitude significantly mediates self-management, particularly in asymptomatic individuals.

Gout

On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

Patient Attitudes Key to Effective Hyperuricemia Self-Management

Jun Ho Jang, MD, PhD, is a professor in the division of hematology-oncology at the Samsung Medical Center.

Jang discusses the results of an open-label extension highlighting the comparative efficacy of this combination therapy versus standard-of-care ravulizumab.

Paroxysmal Nocturnal Hemoglobinuria

Paroxysmal Nocturnal Hemoglobinuria Condition Center page, visitors can find resources on the topics of medical news and expert insight into PNH. Content includes articles, interviews, videos, podcasts, and breaking news on PNH research, treatment, and drug development.

Combination Pozelimab and Cemdisiran Improves LHD Control in PNH, With Jun Ho Jang, MD, PhD

Professor and Laurence A. Boxer Research Professor of Pediatrics and Professor of Pathology, University of Michigan and CS Mott Children’s Hospital, Ann Arbor, Michigan

End-of-study analysis from the HOPE-B trial shows durable endogenous FIX expression, reduced annualized bleeding rates, and a favorable safety profile.


HOPE-B: 5-Year Etranacogene Dezaparvovec Maintains Durable Efficacy and Safety in Hemophilia B, With Steven Pipe, MD

Dr. Sambara emphasizes the importance of collaboration and continuous learning for new retina specialists to thrive in their practice.

Advice on Maintaining Flexibility with Second-Generation Anti-VEGF Agents in Retinal Vascular Diseases

Experts discuss the future of retinal disease treatments, highlighting the promise of new therapies and the need for personalized patient care.

Latest News

Discussing INTEGUMENT-INFANT and Roflumilast Cream 0.05% in Atopic Dermatitis, With Rocco Serrao, MD

Icotrokinra vs Deucravacitinib: Results from the ICONIC-ADVANCE 1 and 2 Trials

Treating High-Impact Areas in Psoriasis: Results From the ICONIC-TOTAL and SPECTREM Trials

Predicting Teduglutide Treatment Response for Pediatric SBS-IF, With Valeria Cohran, MD

Potential Advantages of Oral BTKi in CSU Management