Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety of Repeated Topical Application of Three Concentrations of NF-kappaB Decoy in Adults With Mild-to-Moderate Atopic Dermatitis|
- 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
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||November 2005|
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.
|United States, Florida|
|University of Miami Skin Research|
|Miami, Florida, United States, 33136|
|United States, Minnesota|
|Minnesota Clinical Study Center|
|Fridley, Minnesota, United States, 55432|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Helendale Dermatology & Medical Spa, LLP|
|Rochester, New York, United States, 14609|
|United States, Oregon|
|Oregon Health & Science University, Department of Dermatology|
|Portland, Oregon, United States, 97201|
|United States, Texas|
|Derm Research, Inc.|
|Austin, Texas, United States, 78759|
|Center for Clinical Studies|
|Houston, Texas, United States, 77030|
|Center for Clinical Studies|
|South Houston, Texas, United States, 77058|
|United States, Wisconsin|
|Madison Skin & Research, Inc.|
|Madison, Wisconsin, United States, 53719|
|Study Director:||Andria Langenberg, MD||Anesiva, Inc.|