Tapinarof cream shows safety and efficacy for pediatric atopic dermatitis

In this interview, Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, discusses the clinical utility and safety profile of tapinarof (Vtama) cream 1% for the treatment of atopic dermatitis (AD) in pediatric patients aged as young as 2 years.

Stein Gold highlights that tapinarof, an aryl hydrocarbon receptor (AhR) agonist, demonstrates a favorable safety profile. Common adverse events observed in clinical trials included folliculitis, headache, and upper respiratory tract infections, most of which were mild to moderate in severity.

A key advantage of this topical therapy is its minimal systemic absorption, even in pediatric populations with significant body surface area involvement. Unlike many nonsteroidal topicals that historically caused stinging or burning upon application—a major barrier for patients with sensitive or excoriated skin—tapinarof was well tolerated and comfortable for younger children.

The rapid onset of action is a critical factor in patient adherence. Clinical data showed significant reductions in itch and disease severity as early as week 1. Stein Gold notes that when patients and caregivers see tangible improvement within the first few days, it serves as a powerful motivator to continue treatment. The ease of use—a once-daily, non-steroidal cream that can be applied to any part of the body, including sensitive areas such as the face and eyelids—further simplifies the regimen for busy families.

As the first AhR agonist approved for AD in patients as young as 2 years, tapinarof offers a unique mechanism that downregulates proinflammatory cytokines while simultaneously improving the skin barrier function. This dual action is particularly beneficial for a chronic disease in which the skin barrier is inherently defective.

Stein Gold emphasizes that the treatment goal is “clear or almost clear” skin. Interestingly, clinical data suggested a “durable remission” effect, with many patients maintaining clear skin for several months after stopping the medication. This provides the possibility of “drug holidays,” though she maintains that AD requires a comprehensive long-term management plan.

The reduction of nighttime itch is highlighted as a primary benefit for families. Because pediatric AD often impacts the sleep and well-being of the entire household, a treatment that effectively manages itch allows both children and parents to rest. Stein Gold concludes that having a safe, effective, and simple nonsteroidal option marks an exciting advancement in pediatric dermatology, setting a new standard for maintaining long-term disease control.

Disclosure: Organon & Co

Reference

New data show early and consistent response to Vtama (tapinarof) cream, 1%, in children aged 2+ with atopic dermatitis, including those with associated comorbidities. News release. Organon. November 8, 2025. Accessed November 14, 2025. https://organon2021tf.q4web.com/news/news-details/2025/New-Data-Show-Early-and-Consistent-Response-to-VTAMA-tapinarof-Cream-1-in-Children-Aged-2-with-Atopic-Dermatitis-Including-Those-With-Associated-Comorbidities/default.aspx