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

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

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

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