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News|Articles|March 25, 2024
Tapinarof Cream 1.0% Effective for Atopic Dermatitis: Daily Dose
Author(s)Sydney Jennings
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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
Last week, we reported on findings from the ADORING 1 and ADORING 2 phase 3 clinical trials of tapinarof (VTAMA) cream 1.0% in patients with atopic dermatitis presented at the 2024 American Academy of Dermatology Annual Meeting.
The study
ADORING 1 and ADORING 2 were identical double-blind, randomized, vehicle-controlled studies in which adults and children aged 2 years and older were randomly assigned to in 2:1 ratio to once daily treatment with tapinarof 1.0% or vehicle cream for 8 weeks.
For both studies, investigators specified the primary efficacy endpoint as validated Investigators Global Assessment (vIGA) score of 0 or 1 and at least a 2-grade improvement from baseline to week 8. The secondary endpoint was the proportion of study participants who achieved an improvement of 75% or greater on (EASI 75). The data reflect tapinarof efficacy by race categories as reported by study participants and by Fitzpatrick skin type as assessed by study investigators scoring.
Baseline demographics across the 2 phase 3 trials, according to the study:
White, 44.8 – 56.8%
Black / African American, 26.5 - 35.0%
Asian, 8.8 - 15.3%
Other (American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or other/multiple races), 2.7 – 5.2%
The findings
Approximately 4 in 10 participants who identified as White, Black, and Asian achieved a validated Investigators Global Assessment (vIGA) score of 0, indicating clear skin, with tapinarof cream 1% after 8 weeks of treatment.
Data from the pair of novel studies also showed a significantly greater proportion of participants treated with once-daily tapinarof cream 1% achieved Eczema Area Severity Index improvements of ≥75% (EASI 75) compared to those treated with the vehicle cream from baseline, regardless of skin color.
Authors' comment
"Today’s data on treatment of participants with skin of color highlight VTAMA cream’s promise across all racial groups and skin types in the pivotal trials."
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