NCT00125333

Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: Anesiva, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	NF-kappaB Decoy

Timeline

• Start date: 2005-03-01
• Completion: 2005-11-01
• First posted: 2005-08-01
• Last updated: 2008-11-19

Locations

9 sites across 1 country: United States