Treatment with roflumilast cream 0.15% once daily improved mild to moderate AD in two phase 3 randomized clinical trials of children 6 years or older and adults.
, enrolled patients aged ≥ 6 years with mild to moderate AD who were randomly assigned in a 2:1 ratio toThe primary efficacy endpoint was Validated Investigator Global Assessment for AD success at week 4, defined as a score of 0 or 1 plus improvement of at least two grades from baseline.
Secondary endpoints included vIGA-AD success at week 4 in patients with a baseline score of 3, at least a four-point reduction in the Worst Itch Numeric Rating Scale , and at least a 75% reduction in the Eczema Area and Severity Index at weeks 1, 2, and 4.Significantly more patients receiving roflumilast achieved vIGA-AD success at week 4 vs those in the vehicle group in INTEGUMENT-1 were mild to moderate, with only 0.9% of the patients experiencing serious TEAEs in each trial.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Atopic Dermatitis Atopic Eczema Healthcare And Medical Technology Health And Medical Tech Health And Med Tech Health And Medical Technology Healthcare Technology Medical Technology Children Child Childhood Pediatrics Kids Clinical Research Clinical Trials Clinical Studies Pre-Clinical Trial Double-Blind Study Double-Blind Studies Single-Blind Study
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