Tapinarof Cream 1%, Shows Early and Durable Response in Children With Atopic Dermatitis

New data presented at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, demonstrate that tapinarof cream 1% (VTAMA, Organon) produced early, consistent, and durable improvement in children aged ≥2 years with mild-to-severe atopic dermatitis (AD), including those with comorbid allergic conditions.¹

Results were reported from the phase 3 ADORING 3 open-label extension study, which enrolled children aged 2 to 17 years who had completed prior VTAMA clinical trials. Participants applied tapinarof cream 1% once daily to affected areas for up to 8 weeks.¹

Early improvements in skin clearance were observed, with significant differences in validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response rates as early as week 1 and maintained through week 8. Among children with atopic comorbidities, 42.3% of those treated with tapinarof cream achieved vIGA-AD response compared with 11.8% receiving vehicle (P < 0.0001). In those without comorbidities, response rates were 49.5% with tapinarof vs 14.8% with vehicle (P < 0.0001).

Improvement in Eczema Area and Severity Index (EASI) scores was observed as early as week 2 and sustained through week 8. In children with comorbidities, 54.5% of those using VTAMA achieved improvement vs 21.8% with vehicle (P < 0.0001); in those without comorbidities, 63.1% vs 20.4%, respectively (P < 0.0001).

Patient-reported outcomes also improved early in treatment. Total mean Patient-Oriented Eczema Measure (POEM) and POEM sleep scores showed significant differences by week 1 and were maintained through week 8. For participants with comorbidities, total POEM scores were 6.9 with VTAMA vs 12.0 with vehicle (P < 0.0001), and POEM sleep scores were 0.9 vs 1.4 (P = 0.0003). In those without comorbidities, total POEM scores were 6.7 vs 11.9 (P < 0.0001) and POEM sleep scores 0.6 vs 1.4 (P < 0.0001).

Clinically meaningful improvements in itch (≥4-point Peak Pruritus Numeric Rating Scale [PP-NRS] response) were reported at week 2, with continued improvement through week 8. Among participants with comorbidities, 55.6% receiving VTAMA achieved response vs 36.3% with vehicle (P = 0.0043); among those without comorbidities, 63.3% vs 29.2%, respectively (P < 0.0001).

“As many children with atopic dermatitis may also be living with potential comorbidities such as allergies and asthma that may add to their disease burden, it’s important to understand the effects of approved treatments on this population,” Luz Fonacier, MD, professor of medicine, section head of allergy, and training program director, NYU Grossman Long Island School of Medicine, said in a press release. “These reassuring data show tapinarof cream provided early relief, including on bothersome symptoms such as itch, for children as young as 2 years of age with and without comorbidities.”¹

The analysis also included children with common comorbid allergic conditions, such as asthma, food allergy, and allergic rhinitis. Efficacy and safety outcomes were consistent across subgroups, according to the company.¹

Treatment was well tolerated, with the most common adverse events including folliculitis, contact dermatitis, and headache. No new safety signals emerged relative to prior studies in adults with plaque psoriasis or in children and adults with atopic dermatitis.¹

An estimated 13% of children in the US have AD, many of whom experience significant impacts on sleep, social functioning, and overall quality of life.² Topical corticosteroids and calcineurin inhibitors remain standard first-line therapies, but long-term use is limited by potential adverse effects, particularly in pediatric populations.

Tapinarof, a first-in-class, nonsteroidal aryl hydrocarbon receptor (AhR) agonist, is approved by the US FDA for the treatment of plaque psoriasis in adults and for mild-to-severe AD in patients aged ≥2 years.³ Through AhR activation, tapinarof modulates skin barrier function and inflammatory pathways without systemic immunosuppression.¹

“These results add to the growing body of evidence supporting the efficacy and safety of VTAMA in pediatric patients living with atopic dermatitis, including those with allergic comorbidities,” said the company in a statement.¹

References:

1. New data show early and consistent response to VTAMA (tapinarof) cream 1% in children aged ≥2 years with atopic dermatitis, including those with associated comorbidities. News release. Organon. November 8, 2025. Accessed November 11, 2025. https://www.organon.com/news/new-data-show-early-and-consistent-response-to-vtama-tapinarof-cream-1-in-children-aged-2-with-atopic-dermatitis-including-those-with-associated-comorbidities/
2. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Atopic Dermatitis. Updated: November 2022. Accessed November 11, 2025. https://www.niams.nih.gov/health-topics/atopic-dermatitis
3. Halsey G. Tapinarof Cream, 1%, Gets FDA Green Light for Atopic Dermatitis in Individuals Aged 2 Years and Older. News release. Patient Care. December 16, 2024. https://www.patientcareonline.com/view/tapinarof-cream-1-gets-fda-green-light-for-atopic-dermatitis-in-individuals-aged-2-years-and-older