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Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nanocrystalline silver cream (NPI)
Sponsored by
Nucryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Eczema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Male or female, any race, 18 to 65 years of age. Females must be post-menopausal, surgically sterile, or if of child-bearing potential, not pregnant (confirmed by test) and using an adequate method of birth control. Subjects must have eczema that covers a minimum of 5% total body surface area. Subjects must agree not to use other eczema medications for the 6-week study treatment period. Subjects must not be enrolled in another investigational drug study. Subjects must not be allergic to silver or cocoa butter.

Sites / Locations

  • Radiant Research
  • Medical Affliated Research Centers, Inc.
  • National Jewish Medical & Research Center
  • nTouch Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Sadick Dermatology & Aesthetic Surgery
  • Mount Sinai School of Medicine
  • Clinical Research of Winston-Salem, Inc.
  • University Hospitals of Cleveland
  • Radiant Research
  • Oregon Health & Science University
  • Radiant Research
  • National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
  • Radiant Research
  • ACE Research Specialists, Inc.
  • Radiant Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 21, 2004
Last Updated
June 23, 2005
Sponsor
Nucryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00076375
Brief Title
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nucryst Pharmaceuticals

4. Oversight

5. Study Description

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, 0.5% 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Atopic Dermatitis, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nanocrystalline silver cream (NPI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male or female, any race, 18 to 65 years of age. Females must be post-menopausal, surgically sterile, or if of child-bearing potential, not pregnant (confirmed by test) and using an adequate method of birth control. Subjects must have eczema that covers a minimum of 5% total body surface area. Subjects must agree not to use other eczema medications for the 6-week study treatment period. Subjects must not be enrolled in another investigational drug study. Subjects must not be allergic to silver or cocoa butter.
Facility Information:
Facility Name
Radiant Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Medical Affliated Research Centers, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
National Jewish Medical & Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
nTouch Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Radiant Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Radiant Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Radiant Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Radiant Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Sadick Dermatology & Aesthetic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Clinical Research of Winston-Salem, Inc.
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Radiant Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
ACE Research Specialists, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Radiant Research
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nucryst.com
Description
Study sponsor's web site providing information about nanocrystalline silver.
URL
http://www.aad.org
Description
American Academy of Dermatology web site providing reference information on atopic dermatitis and other skin conditions.
URL
http://www.nationaleczema.org
Description
National Eczema Association web site providing resources and support to those with eczema.

Learn more about this trial

Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)

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