Analysis: Tapinarof Cream Yields Improved Sleep in Pediatric AD
Key Takeaways
A pooled subanalysis of ADORING 1 and 2 indicated tapinarof cream, 1% (VTAMA, Organon) improved sleep-related patient-reported outcomes in children with moderate to severe atopic dermatitis (AD) as early as week 1.
Improvements in POEM and DFI sleep subdomains were observed across pediatric age groups down to 2 years of age through week 8.
Safety was consistent with prior studies; folliculitis, headache, and nasopharyngitis were the most commonly reported adverse events.
- Full results will be presented at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting (AAAAI) meeting in Philadelphia.
A new analysis of the phase 3 ADORING 1 and ADORING 2 trials showed that tapinarof cream, 1% (VTAMA, Organon) was associated with early and sustained improvements in sleep-related patient-reported outcomes in pediatric patients with moderate to severe atopic dermatitis (AD), including children as young as 2 years.
A news release from the manufacturer, Organon, said the full results are slated for presentation at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting in Philadelphia.
According to the release, ADORING 1 and ADORING 2 enrolled adults and children aged 2 years and older (N = 813) who were randomized to once-daily tapinarof cream or vehicle for 8 weeks. The sleep analysis included 654 children aged 2 to 17 years from the studies. The investigators used the Patient-Oriented Eczema Measure (POEM) and the Dermatitis Family Impact (DFI) questionnaire to assess sleep subdomains. Mean POEM sleep subdomain scores improved with tapinarof vs. vehicle as early as week 1 in children aged 2 to 6 years and 12 to 17 years and at week 4 in those aged 7 to 11 years. At week 8, mean changes in POEM sleep scores were −1.9 vs. −0.9 (P < 0.0001) for ages 2 to 6 years, −1.5 vs. −1.0 (P = 0.0029) for ages 7 to 11 years, and −1.2 vs. −0.6 (P < 0.0001) for ages 12 to 17 years.
Improvements were also observed in DFI sleep subdomain scores among family members of affected children, Researchers also reported statistically significant differences in DFI sleep subdomain scores among family members of affected children, which favored tapinarof through week 8 across age groups. Folliculitis, headache, and nasopharyngitis were the most frequently reported treatment-emergent adverse events (≥5% in any group) in the analysis.
“These findings demonstrate early and sustained improvements in sleep-related measures, including for those as young as two years of age,” said Juan Camilo Arjona Ferreira, MD, Head of R&D and Chief Medical Officer at Organon, in the press release. "Sleep disturbance is an important and measurable aspect of pediatric atopic dermatitis, and these positive results reinforce our commitment to advancing therapies that address meaningful treatment outcomes across chronic skin conditions. We are encouraged by these new findings and look forward to continuing to disseminate data that are clinically relevant for patients, caregivers, and prescribers.”
Source: Organon press release. February 27, 2026