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Dermavant Sciences recently announced positive results for VTAMA (tapinarof cream, 1%) for treatment of atopic dermatitis in children aged as young as 2 years.
VTAMA (tapinarof cream, 1%; Dermavant Sciences) has shown positive results in children aged as young as 2 years with atopic dermatitis (AD), according to Dermavant Sciences.
Philip M. Brown, MD, JD, chief medical officer of Dermavant, said tapinarof has shown favorable results for safety, pharmacokinetics, and clinical improvement, along with a low incidence of adverse events.
There were 36 pediatric patients enrolled in the study aged 2 to 17 years old with an investigator's global assessment score of 3 or more during screening, implying moderate to severe AD. Patients underwent 4 weeks of treatment with tapinarof under maximal usage conditions.
The study evaluated the same 1% cream that is undergoing ADORING 1 and ADORING 2 pivotal trials and has been approved by the US Food and Drug Administration to treat plague psoriasis in adult patients.Dermavant plans to announce results from the trials in the first half of 2023.
In the study, tapinarof was tolerated by patients even in areas of sensitive skin. There was also minimal to no systemic exposure confirmed for patients with up to 90% body surface area (BSA) affected. The mean BSA in the study was 43%.
AD affects over 26 million people in the United States alone and is most common in pediatric patients. Up to 30% of children worldwide are afflicted with AD, experiencing red, swollen, cracked skin.
AD frequently causes itching leading to sleep disturbances and fatigue that makes children inattentive at school. The visibility and discomfort of AD could also lead to social and emotional distress.
Tapinarof is currently the top branded topical treatment for plague psoriasis. Adverse events include contact dermatitis, nasopharyngitis, folliculitis, itching, headache, and influenza.
The full results on the effects of tapinarof in pediatric AD will likely be presented at a future medical meeting, according to Dermavant.
Dermavant announces highly favorable results from pediatric maximal usage study of VTAMA® (tapinarof) cream, 1% in atopic dermatitis.Dermavant. November 8, 2022. Accessed November 15, 2022.https://www.dermavant.com/dermavant-announces-compelling-results-from-pediatric-maximal-usage-study-of-vtama-tapinarof-cream-1-in-atopic-dermatitis/