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Home > "P" Clinical Trials Conditions > Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)  Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
For Condition: Atopic Dermatitis,Eczema
Status: Completed
Sponsor(s): Nucryst Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 180
Location and Contact Information:
Sadick Dermatology & Aesthetic Surgery
New York City, New York, 10021
United States
Radiant Research
Greer, South Carolina, 29605
United States
Radiant Research
Lakewood, Washington, 98499
United States
Radiant Research
Overland Park, Kansas, 66215
United States
National Jewish Medical & Research Center
Denver, Colorado, 80206
United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
ACE Research Specialists, Inc.
Nashville, Tennessee, 37203
United States
Radiant Research
West Palm Beach, Florida, 33407
United States
National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
Charleston, South Carolina, 29407
United States
Radiant Research
Boise, Idaho, 83704
United States
nTouch Research
Washington D.C., District of Columbia, 20037
United States
Radiant Research
St. Louis, Missouri, 63141
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Radiant Research
Philadelphia, Pennsylvania, 19115
United States
Clinical Research of Winston-Salem, Inc.
Winston Salem, North Carolina, 27103
United States
Radiant Research
Columbus, Ohio, 43212
United States
Radiant Research
Birmingham, Alabama, 35209
United States
Medical Affliated Research Centers, Inc.
Huntsville, Alabama, 35801
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: 32101-2-01;
Study Start Date: November 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076375
Other Eczema Studies:
1. Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
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Other Eczema Clinical Trials
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Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
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