Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema) - Full Text View

Sponsored by:	Nucryst Pharmaceuticals
Information provided by:	Nucryst Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00076375

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis Eczema	Drug: Nanocrystalline silver cream (NPI)	Phase II

MedlinePlus related topics: Eczema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Nucryst Pharmaceuticals:

Estimated Enrollment:	180
Study Start Date:	November 2003
Estimated Study Completion Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076375

Locations

United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
Medical Affliated Research Centers, Inc.
Huntsville, Alabama, United States, 35801
United States, Colorado
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
United States, District of Columbia
nTouch Research
Washington, District of Columbia, United States, 20037
United States, Florida
Radiant Research
West Palm Beach, Florida, United States, 33407
United States, Idaho
Radiant Research
Boise, Idaho, United States, 83704
United States, Kansas
Radiant Research
Overland Park, Kansas, United States, 66215
United States, Missouri
Radiant Research
St. Louis, Missouri, United States, 63141
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sadick Dermatology & Aesthetic Surgery
New York, New York, United States, 10021
United States, North Carolina
Clinical Research of Winston-Salem, Inc.
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research
Columbus, Ohio, United States, 43212
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Radiant Research
Philadelphia, Pennsylvania, United States, 19115
United States, South Carolina
National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
Charleston, South Carolina, United States, 29407
Radiant Research
Greer, South Carolina, United States, 29605
United States, Tennessee
ACE Research Specialists, Inc.
Nashville, Tennessee, United States, 37203
United States, Washington
Radiant Research
Lakewood, Washington, United States, 98499

Sponsors and Collaborators

Nucryst Pharmaceuticals

More Information

Additional Information:

Study sponsor's web site providing information about nanocrystalline silver. This link exits the ClinicalTrials.gov site

American Academy of Dermatology web site providing reference information on atopic dermatitis and other skin conditions. This link exits the ClinicalTrials.gov site

National Eczema Association web site providing resources and support to those with eczema. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	32101-2-01
Study First Received:	January 21, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00076375 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nucryst Pharmaceuticals:

Atopic Dermatitis
Eczema

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009