Atopic Dermatitis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Two Concentrations of Nanocrystalline Silver Cream (NPI) Applied Twice Daily in Adults With Mild to Moderate Atopic Dermatitis
Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat
dressings, which have been approved for the treatment of burns and other wounds. Silver has
been used for decades as an effective antimicrobial agent. In animal studies,
nanocrystalline silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus,
nanocrystalline silver cream is being evaluated in the treatment of inflammatory skin
conditions such as atopic dermatitis (eczema).
Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will
be enrolled in this study. Subjects will be randomly assigned to treatment with placebo,
0.5% NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and
safety will be performed weekly. Upon completion of the study, subjects may be eligible for
12 weeks of open-label treatment with 1% NPI.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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