VTAMA® Phase 3 Data Shows Sustained Low Atopic Dermatitis Activity After Treatment-Free Interval
Organon (NYSE: OGN), a global healthcare company specializing in women’s health, announced the results of a new analysis from the Phase 3 ADORING 3 open-label, long-term extension study. The study evaluated VTAMA® (tapinarof) cream, 1%, applied once daily in adults and children 2 years and older with atopic dermatitis (AD). The analysis showed that AD disease activity remained mild in patients who had achieved treatment success and then underwent a treatment-free interval lasting an average of 80 days. These findings were presented at a late-breaking research session at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
Organon (NYSE: OGN), a global healthcare company committed to improving women’s health, has announced the results of a new analysis from the Phase 3 ADORING 3 study, an open-label, long-term extension trial of VTAMA® (tapinarof) cream, 1%. This study evaluates the efficacy of VTAMA cream in treating adults and children aged 2 years and older with atopic dermatitis (AD), commonly known as eczema. The findings suggest that the treatment’s benefits may last beyond the duration of active use, with patients experiencing sustained mild disease activity even after a treatment-free interval.
Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and irritated skin. It affects millions worldwide, particularly children, and remains a significant challenge for both patients and healthcare providers. One of the most troublesome aspects of AD is the itch, which often leads to a reduction in quality of life and disruptions in daily activities, especially at night.
According to Dr. Jonathan Silverberg, M.D., Ph.D., M.P.H., of George Washington University School of Medicine and Health Sciences, “For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived. For some, their disease rapidly reappears after a break from treatment.
I am encouraged by these results, as they show that after taking a break from treatment with VTAMA cream, patients’ AD remained mild. These data support the use of VTAMA cream to potentially provide lasting relief from the itch, which is the most burdensome symptom of AD.”
The ADORING 3 Study
The ADORING 3 study was a 48-week open-label, long-term extension study that enrolled 728 patients. These patients had either participated in the pivotal Phase 3 ADORING 1 and ADORING 2 trials or were new patients aged 2–17 years with mild, moderate, or severe AD.
Patients who had achieved clear skin—defined by a validated Investigator Global Assessment for AD (vIGA-AD™) score of 0—were asked to stop using VTAMA cream and enter a treatment-free period. They were monitored for maintenance of their disease status, with the goal of keeping the vIGA-AD score at 0 (clear) or 1 (almost clear). If their disease worsened to a vIGA-AD score of 2 or higher (mild or above), they were retreated with VTAMA cream until their disease cleared again.
The analysis found that, after the first treatment-free interval, which lasted an average of 79.8 days, 84% of patients maintained a vIGA-AD score of 2 (mild). Moreover, itch—measured using the Peak Pruritus Numerical Rating Scale (PP-NRS) ranging from 0 to 10—remained low with a mean weekly score of 2.9. The mean Eczema Area and Severity Index (EASI) score was 3.4, confirming that most patients still had mild disease activity even after the break from treatment.
Safety Profile
The most common treatment-emergent adverse events (TEAEs) observed in the ADORING 3 study included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infections (6.9%). Importantly, the rate of study discontinuations due to TEAEs was low, at just 2.6%. Adverse events of special interest, including follicular events, contact dermatitis, and headaches, were mostly mild or moderate in severity and associated with low discontinuation rates (1.0%, 0.4%, and 0%, respectively).
Juan Camilo Arjona Ferreira, M.D., Head of Research and Development and Chief Medical Officer at Organon, stated, “These data reinforce the efficacy of VTAMA cream in atopic dermatitis, including its durability of effect. The results are especially encouraging for patients as young as two years old. Atopic dermatitis can have a profound impact on the lives of patients and their caregivers. The possibility of receiving more than two months of relief without the need for constant reapplication of treatment is a meaningful improvement in managing this chronic condition.”
FDA Approvals for VTAMA Cream
In December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream, 1%, for the topical treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. This approval followed the FDA’s previous decision to approve VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in adults in May 2022.
About ADORING
ADORING is the Phase 3 clinical development program for VTAMA cream, 1%, consisting of three trials: ADORING 1, ADORING 2, and ADORING 3. The findings from the ADORING studies highlight the potential of VTAMA cream to provide effective and durable treatment for patients with atopic dermatitis.
Atopic Dermatitis and Its Impact
Atopic dermatitis is one of the most common inflammatory skin diseases, affecting more than 26 million people in the U.S. and up to 10% of adults worldwide. It is most prevalent in children, with up to 20% of children globally affected. The condition causes itchy, red, swollen, and cracked skin, often in areas such as the folds of the arms, behind the knees, hands, face, and neck. Itchiness, especially at night, remains the most troublesome symptom for patients.
About Organon
Organon is an independent global healthcare company with a mission to improve the health of women throughout their lives. The company’s portfolio includes over 70 medicines in women’s health, biosimilars, and other therapeutic areas. Organon is committed to addressing the needs of patients and their caregivers, especially in areas like atopic dermatitis, where innovative treatments can significantly improve quality of life.
