New Analysis of Organon’s VTAMA® (tapinarof) cream, 1%, Phase 3 Data Showed Early and Consistent Improvement in Patient-Reported Sleep Subdomains in Pediatric Patients Down to 2 Years of Age with Atopic Dermatitis
- Clinically meaningful improvements in sleep scores, as measured by subdomains of the Patient-Oriented Eczema Measure (POEM) and Dermatitis Family Impact (DFI) assessments, were observed as early as week 1 and continued through week 8
“Sleep disturbance is a significant problem for children with atopic dermatitis and their families, and one that I always take time to address in my clinic,” said Dr.
In the ADORING 1 and ADORING 2 pivotal trials, adults and children (≥2 years; N=813) with moderate to severe AD were randomized 2:1 to VTAMA cream or vehicle once daily for 8 weeks. These findings presented at AAAAI 2026 come from a sub‑analysis of pooled data from 654 children aged 2 to 17 years enrolled in ADORING 1 and ADORING 2. Clinically relevant improvements in sleep subdomains of patient-reported outcomes, as measured by POEM and DFI scores, were seen across all age groups, including pediatric patients down to age 2 with moderate to severe AD and family members of patients aged 2-15 years.
Notable findings include1:
- Mean POEM sleep subdomain scores significantly improved as early as week 1 with VTAMA cream versus vehicle for children aged 2-6 and 12-17, with improvements in children aged 7-11 observed by week 4.
- Mean changes in POEM sleep scores with VTAMA cream versus vehicle at week 8 were clinically significant across age groups: -1.9 vs. -0.9 for children aged 2-6 (P<0.0001), -1.5 vs. -1.0 for children aged 7-11 (P=0.0029), and -1.2 vs. -0.6 for children aged 12-17 (P<0.0001).
- Mean DFI sleep subdomain scores significantly improved as early as week 1 with VTAMA cream versus vehicle in patients aged 12-15 and as early as week 2 for children aged 2-6 and 7-11.
- Clinically significant improvements in DFI sleep subdomain scores continued through week 8 with VTAMA cream versus vehicle: -1.1 vs. -0.6 for children aged 2-6 (P=0.0002), -0.6 vs. -0.4 for children aged 7-11 (P=0.0049), and -0.4 vs. -0.2 for children aged 12-15 (P=0.0283).
Consistent with the prescribing information, the most frequently reported (≥5% in any group) treatment-emergent adverse events in the ADORING 1 and ADORING 2 clinical trials were folliculitis, headache, and nasopharyngitis.
“These findings demonstrate early and sustained improvements in sleep-related measures, including for those as young as two years of age,” said
In
About the Phase 3
ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.
INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:
- the topical treatment of plaque psoriasis in adults
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older
SELECTED SAFETY INFORMATION
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
Before prescribing VTAMA cream, please read the Prescribing Information .
For more information about VTAMA (tapinarof) cream, 1%, visit www.vtamahcp.com.
About Atopic Dermatitis (AD)
AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in
Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s intent to present results about VTAMA as a treatment option for AD and continuing to disseminate clinically relevant data about VTAMA. Forward-looking statements may be identified by words such as “will,” and “look forward to” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the
© 2026 Organon group of companies. All rights reserved. US-VTA-113179 02/26
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1 Boguniewicz M, Eichenfield LF, Kwong P, Hebert AA. Improvement in sleep and family impact for pediatric patients down to two years of age with atopic dermatitis treated with tapinarof cream 1% once daily in two pivotal phase 3 trials. Poster presented at: |
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2 Atopic dermatitis. |
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3 Eczema stats. |
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4 Global Report on Atopic Dermatitis 2022. |
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