Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125333
Status:
COMPLETED
Last Update Posted:
2008-11-19
First Post:
2005-07-28
Brief Title:
Topical NF-kappaB Decoy in the Treatment of Atopic Dermatitis
Sponsor:
Anesiva Inc
Organization:
Anesiva Inc
Study Overview
Official Title:
A Phase 12 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
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None