Tapinarof Cream Clears Skin, Eases Itch Within 1 Week in Kids as Young as 2 Years

A post-hoc pooled analysis of 2 pivotal phase 3 trials evaluating tapinarof cream 1% (Vtama) in patients with moderate to severe atopic dermatitis demonstrated statistically significant improvements in disease severity and itch beginning as early as week 1 of treatment, including in pediatric patients as young as 2 years of age.

“The new findings from this analysis demonstrate significant improvements across key clinical endpoints, including reductions in disease severity and itch, as early as week 1,” said Linda Stein Gold, MD, director of Clinical Research and Division Head of Dermatology, Henry Ford Health System, in a press release from Organon. “Seeing these positive outcomes in many patients across the study, especially since 80% of the trial participants were children, highlights the potential of [tapinarof] cream to address common symptoms, such as itch, early in the treatment course and provides healthcare providers with an evidence-based option to help manage the disease.”

Trial and Regulatory Overview

The data originated from ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), 2 randomized, vehicle-controlled, double-blind, 8-week phase 3 pivotal trials conducted as part of the ADORING clinical development program for tapinarof in atopic dermatitis. The pooled analysis presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, was a post-hoc sub-analysis of combined data from ADORING 1 and ADORING 2.¹

Adults and children aged 2 years and older (N=813) with moderate to severe atopic dermatitis were randomized to tapinarof cream 1% or vehicle applied once daily for 8 weeks. The primary and key secondary endpoints included the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), the Eczema Area and Severity Index 75 (EASI75), and the Peak Pruritus Numerical Rating Scale (PP-NRS).¹

According to study results, statistically significant improvements versus vehicle were observed across all 3 endpoints as early as week 1.¹

At week 1, a vIGA-AD response, which was defined as clear (score of 0) or almost clear (score of 1) with a ≥2-grade improvement from baseline, was achieved in 5.8% of tapinarof-treated patients versus 1.6% in the vehicle group (P=.0315). By week 8, the vIGA-AD response rate was 45.9% versus 15.9% (P <.0001).

EASI75 response at week 1 was achieved in 9.0% of tapinarof-treated patients versus 3.3% receiving vehicle (P=.0164), increasing to 57.4% versus 22.1% at week 8 (P <.0001).

Meaningful itch improvement, defined as a ≥4-point reduction in PP-NRS score among patients with a baseline score of ≥4, was observed in 18.8% of tapinarof-treated patients at week 1 versus 11.3% in the vehicle group (P=.0128), and in 59.3% versus 33.5% at week 8 (P <.0001).

Additionally, the analysis reported that 96.9% of patients in the tapinarof arm achieved any measurable EASI improvement from baseline at week 8.¹

With regard to safety, the investigators reported that the treatment was well tolerated. Treatment-emergent adverse events occurring in ≥3% of any group included folliculitis, headache, upper respiratory tract infection, and nasopharyngitis.

The full prescribing information for tapinarof in the atopic dermatitis indication lists upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain as the most common adverse reactions (incidence ≥1%).¹

Drug Background

Tapinarof is a first-in-class, non-steroidal, small-molecule aryl hydrocarbon receptor (AhR) agonist.

According to the prescribing information, its mechanism involves modulation of the AhR pathway, which plays a role in skin barrier function and inflammatory signaling. It is formulated as a 1% topical cream applied once daily and carries approvals from the US Food and Drug Administration for both plaque psoriasis in adults and atopic dermatitis in adults and pediatric patients aged 2 years and older.¹

Limitations and Next Steps

The post-hoc, pooled, sub-analysis design warrants interpretive caution. Post-hoc analyses are hypothesis-generating rather than confirmatory, and while the underlying ADORING 1 and ADORING 2 trials were prospectively powered and conducted under controlled conditions, the combined subanalysis was not a pre-specified primary endpoint analysis. These findings should be viewed as supportive and contextualizing, rather than as new primary efficacy evidence.

Several limitations should be noted. As stated above, this was a post-hoc pooled analysis, and its findings are exploratory rather than confirmatory in nature. Additionally, the 8-week treatment duration of the ADORING 1 and ADORING 2 trials limits conclusions about long-term efficacy maintenance; the ongoing ADORING 3 open-label extension (48 weeks) may provide more durable data, though it lacks a vehicle control arm.

“In treating atopic dermatitis, our goal as healthcare providers is to find therapies that deliver fast and clinically meaningful skin clearance and itch reduction, and a favorable safety profile,” Stein Gold remarked.

References

1. Organon. Organon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of Age. Business Wire. Published March 27, 2026. Accessed March 27, 2026. https://www.businesswire.com/news/home/20260327556082/en/Organon-Debuts-New-Analysis-of-VTAMA-tapinarof-cream-1-Phase-3-Pooled-Data-Demonstrating-Early-and-Consistent-Skin-Clearance-and-Itch-Improvement-in-Atopic-Dermatitis-Patients-Down-to-2-Years-of-Age
2. Silverberg JI, Eichenfield LF, Stein Gold L, Arjona Ferreira JC, Bissonnette R. Efficacy and safety of tapinarof cream 1% once daily monotherapy in adults and children with atopic dermatitis: pooled results from ADORING 1 and 2. Presented at: American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.
3. Organon. HIGHLIGHTS of PRESCRIBING INFORMATION.; 2024. Accessed March 27, 2026. https://www.organon.com/product/usa/pi_circulars/v/VTAMA/vtama_pi_ppi_combo.pdf