Skin Application-Site Reactions (%)6
- † Six-week, double-blind phases of two 6-week, multicentre trials in patients aged 2 to 17 years with mild to moderate eczema
‡ Data from a 1-year safety study in pediatric patients aged 2 to 17 years with mild to moderate eczema (N=347).6
- § Data from an active-controlled adult study.6
- Overall application-site reactions were mild to moderate, occurred early in treatment, and were transient in nature.3
The most common adverse reactions seen in clinical studies included application-site burning,
headache, pharyngitis, nasopharyngitis, cough, influenza, pyrexia, and viral infection.6
There were no reported adverse reactions (≥1%) of HPA axis suppression, atrophy or telangiectasia
in clinical studies.6
In clinical trials, 48 (4%) of the 1,171 ELIDEL patients and 13 (3%) of 408 vehicle-treated patients
discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to
application-site reactions and cutaneous infections.6
- In clinical studies, skin papillomas or warts were observed in 1% of ELIDEL patients.
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