Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076375
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2004-01-21
Brief Title:
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis Eczema
Sponsor:
Nucryst Pharmaceuticals
Organization:
Nucryst Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-04
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:
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 05 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
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 05 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
Detailed Description:
None
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