FDA Approved Vtama Cream for Treating Atopic Dermatitis in Adults, Children

The FDA approved Vtama (tapinarof) cream 1% for treating atopic dermatitis (AD) in adults and children as young as 2-years-old. This approval is the latest option for a skin condition that impacts millions, especially children and those of color.

Atopic dermatitis is a chronic skin condition that causes inflammation, itching and dryness and is more common in Black and Hispanic children, with Black children being 1.7 times more likely to develop it.

Organon, the company behind Vtama, received FDA approval ahead of its scheduled date of March 12, 2025.

The FDA’s decision was based on studies called the ADORING trials, which tested Vtama cream in patients aged two and older with moderate to severe AD. After 8 weeks, nearly half of the patients treated with VTAMA achieved clear or almost clear skin compared to only about 14% in the placebo group.

In addition, patients reported reductions in itching, a symptom that affects their quality of life.

Adelaide A. Hebert, M.D., a pediatric dermatologist and lead investigator for the ADORING program, highlighted the importance of these results.

“Vtama cream has the potential to bring much-needed relief to children suffering from this disease,” Hebert said. “The reduction in itch is particularly meaningful for patients and their families.”

A follow-up study, ADORING 3, examined the long-term safety and effectiveness of Vtama cream over 48 weeks.

Results showed that many patients could stop using the cream for about 80 days before symptoms returned. When symptoms did come back, reapplying the cream effectively cleared the skin again.

The safety profile remained consistent with earlier studies, confirming that Vtama is safe for long-term use.

Beyond its immediate benefits, Vtama’s approval is especially critical for communities that have historically been underrepresented in dermatology research.

Andrew F. Alexis, M.D., vice-chair for Diversity and Inclusion in Dermatology at Weill Cornell Medicine, said there’s a major gap in addressing the needs of patients with skin of color.

“Clinical trials often don’t reflect the diversity of the disease population.”

In addition to treating atopic dermatitis, Vtama had earlier success in 2022 when it became the first non-steroidal topical treatment for plaque psoriasis in over 25 years.

With atopic dermatitis, it’s approved for use without restrictions on duration or the percentage of body surface area affected.