The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is working) will also be evaluated.
This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the safety of repeated application of three concentrations of NF-kappaB Decoy in approximately 75 subjects with mild-to-moderate atopic dermatitis. The face, hands, feet, scalp, or groin may NOT be treated. Other treatment agents are currently available for atopic dermatitis but present significant potential side effects (topical steroids) or are potent immunosuppressives (topical calcineurin inhibitors) with pending longer-term safety data. NF-kappaB Decoy is a double-stranded deoxyribonucleic acid (DNA) oligodeoxynucleotide that mimics the NF-kappaB binding sequence on the chromosomal DNA, thereby inhibiting the production of the inflammatory response triggered by NF-kappaB. This mechanism of action presents a unique treatment modality. A comprehensive series of nonclinical data have produced promising results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
University of Miami Skin Research
Miami, Florida, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Mount Sinai School of Medicine
New York, New York, United States
To evaluate the safety and tolerability of twice-daily topical application of three concentrations of NF-kappaB Decoy in adult subjects with mild-to-moderate atopic dermatitis
To make a preliminary evaluation of the efficacy of the topical NF-kappaB Decoy in the treatment of mild-to-moderate atopic dermatitis in adult subjects
To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy
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Helendale Dermatology & Medical Spa, LLP
Rochester, New York, United States
Oregon Health & Science University, Department of Dermatology
Portland, Oregon, United States
Derm Research, Inc.
Austin, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies
South Houston, Texas, United States
Madison Skin & Research, Inc.
Madison, Wisconsin, United States