Highlights 

  • VTAMA cream demonstrated early improvements in skin clearance and disease severity in children aged 2-17. 
  • Reductions observed in itch, patient-reported outcomes, and EASI scores were clinically meaningful. 
  • Safety profile aligned with previous studies; most common events were folliculitis and headache. 

Organon (NYSE:OGN) reported findings from a sub-analysis of pooled data from the Phase 3 ADORING 1 and ADORING 2 trials at the 2025 American College of Allergy, Asthma & Immunology Annual Scientific Meeting. The analysis assessed VTAMA® (tapinarof) cream, 1%, in children aged 2-17 with atopic dermatitis, including those associated comorbidities such as asthma, allergic rhinitis, and food allergies. 

Results indicated that VTAMA cream produced early and consistent improvements in skin clearance, eczema severity, and patient-reported outcomes, independent of comorbidity status, through week 8. 

Efficacy Outcomes 

  • Skin Clearance and Severity: Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) response rates improved by week 1 and were maintained through week 8. Children with comorbidities had a 42.3% response with VTAMA versus 11.8% with vehicle (p<0.0001), and those without comorbidities had 49.5% versus 14.8%, respectively (p<0.0001). 
  • EASI Scores: Eczema Area and Severity Index improvements were noted from week 2 and sustained through week 8. Among children with comorbidities, 54.5% showed improvement versus 21.8% with vehicle, and 63.1% versus 20.4% without comorbidities (p<0.0001). 
  • Patient-Reported Outcomes: Improvements in total POEM and POEM sleep scores were observed as early as week 1 and maintained through week 8. 
  • Itch Reduction: Clinically meaningful reductions in Peak Pruritus Numeric Rating Scale (PP-NRS ≥4 points) were evident by week 2 and sustained through week 8. 

Safety Profile 

The sub-analysis reported a safety profile consistent with previous pivotal trials. The most frequently observed adverse events in children aged 2-17 included folliculitis (7.8%), upper respiratory tract infection (4.6%), and headache (3.7%). 

Management Commentary 

Rafael Chaves Cardona, MD, Head of U.S. Medical Affairs and Outcomes Research at Organon, stated: 
“We are proud to announce data from this new sub-analysis demonstrating early and consistent skin clearance with VTAMA cream, as well as other clinically meaningful improvements in key atopic dermatitis measures in children 2 years and older, regardless of comorbidity status. This study represents the largest pediatric dataset to date for VTAMA, and when added to the pivotal trial data, it supports Organon’s commitment to offering treatment options with a favorable safety and efficacy profile for children 2 years and older.” 

About VTAMA® and Atopic Dermatitis 

VTAMA® cream, 1%, is an aryl hydrocarbon receptor (AhR) agonist approved by the FDA for topical treatment of plaque psoriasis in adults and AD in adults and children aged 2 years and older. Atopic dermatitis affects an estimated 26 million people in the U.S., with up to 20% of children globally affected, many of whom have comorbid allergic conditions. 

The Phase 3 ADORING program included ADORING 1 and ADORING 2, both 8-week pivotal trials, and ADORING 3, a 48-week open-label extension trial.