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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00076375
Recruitment Status : Completed
First Posted : January 23, 2004
Last Update Posted : June 24, 2005
Information provided by:
Nucryst Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Nanocrystalline silver cream (NPI) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2003
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00076375

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
Sadick Dermatology & Aesthetic Surgery
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Clinical Research of Winston-Salem, Inc.
Winston Salem, North Carolina, United States, 27103
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Radiant Research
Columbus, Ohio, United States, 43212
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

Additional Information: Identifier: NCT00076375     History of Changes
Other Study ID Numbers: 32101-2-01
First Posted: January 23, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004

Keywords provided by Nucryst Pharmaceuticals:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases