Key Takeaways:
- Tapinarof cream 1% improved atopic dermatitis outcomes across all evaluated age groups.
- Clinical benefits were observed as early as Week 2.
- Most adverse events were mild or moderate, with fewer discontinuations than vehicle.
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Tapinarof Cream 1% Demonstrates Efficacy Across Pediatric Groups with Eczema
Organon reports pooled phase 3 data showing tapinarof cream (VTAMA) improved atopic dermatitis severity across pediatric and adult age groups by Week 8.
New findings at the 2026 Society for Pediatric Dermatology (SPD) Annual Meeting suggest tapinarof 1% cream (VTAMA) use led to consistent improvements in disease severity among pediatric patients with moderate to severe atopic dermatitis, with the treatment’s effects observed early across multiple age cohorts.1,2
The findings, presented by Organon, come from a post hoc pooled analysis of the phase 3 ADORING 1 and ADORING 2 clinical trials, evaluating the efficacy and safety of once-daily tapinarof cream. The cream was compared with vehicle in adults and children aged 2 years and older with moderate to severe atopic dermatitis.1,2
“Patients can experience atopic dermatitis differently across all stages of life. In my practice I might treat a toddler differently than a teenager or adult. Having robust, age-stratified data gives us real confidence in how we counsel patients and families,” Luz Fonacier, MD, professor NYC Grossman Long Island School of Medicine and lead author of the poster being presented at SPD, said in a statement.1
Early Improvements Observed Across Pediatric and Adult Age Groups
The analysis included 813 participants enrolled in the ADORING 1 and ADORING 2 pivotal studies, who had been randomized in a 2:1 ratio to receive either tapinarof cream or vehicle once daily for 8 weeks.2 Investigators examined outcomes by age, including children aged 2–6 years, 7–11 years, adolescents aged 12–17 years, and adults aged 18 years and older. Pediatric participants represented the majority of the study population, accounting for 80.4% of enrolled patients.
According to the analysis, improvements were evident by week 2, the first post-baseline assessment, and continued through the end of the 8-week treatment period.
At Week 8, a greater proportion of patients receiving tapinarof cream achieved a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response compared with those receiving vehicle across all age groups. Response rates were 56.3% versus 11.8% among children aged 2–6 years, 44.9% versus 23.8% in those aged 7–11 years, 48.8% versus 13.4% among adolescents aged 12–17 years, and 38.0% versus 18.1% in adults.
Pooled Analysis Shows Improvements in EASI75 and Favorable Safety Profile
Investigators also evaluated the proportion of patients achieving at least a 75% improvement in Eczema Area and Severity Index (EASI75) scores by Week 8. Across each age category, patients treated with tapinarof cream demonstrated higher response rates than those receiving vehicle.
Among children aged 2–6 years, 70.2% achieved EASI75 compared with 20.5% in the vehicle group. Corresponding rates were 53.6% versus 31.3% for patients aged 7–11 years, 62.2% versus 18.3% for adolescents aged 12–17 years, and 50.8% versus 20.6% among adults.
Safety findings from the pooled analysis were consistent with previous clinical experience. The most commonly reported treatment-emergent adverse events included folliculitis, headache, and nasopharyngitis, with most events characterized as mild or moderate. Investigators also reported that discontinuations related to treatment-emergent adverse events occurred less frequently among patients receiving tapinarof cream than among those treated with vehicle.
“This data is encouraging, as it shows whether patients were young children or adults, have moderate or severe atopic dermatitis, VTAMA cream demonstrated clinically meaningful early and consistent improvements in skin clearance,” Fonacier said in a statement.1
Tapinarof cream is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults and atopic dermatitis in adults and pediatric patients aged 2 years and older.1 The phase 3 ADORING clinical development program included the 8-week ADORING 1 and ADORING 2 pivotal studies, along with ADORING 3, a 48-week open-label extension trial evaluating longer-term treatment.
References
New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults. Organon. July 24, 2026. Accessed July 27, 2026. https://www.organon.com/news/new-analysis-of-phase-3-pooled-data-for-organons-vtama-tapinarof-cream-1-demonstrates-early-consistent-improvements-in-atopic-dermatitis-patients-across-pediatric-age-groups-and-in/.
Fonacier L, Boguniewicz M, Ohayon J, et al. Tapinarof cream 1% in atopic dermatitis: consistent efficacy across age groups from pooled ADORING trials. Poster presented at: Society for Pediatric Dermatology (SPD) Annual Meeting; July 23, 2026; Minneapolis, MN.
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