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

Phase 2

Completed

• Conditions: Atopic Dermatitis; Eczema

• Registration Number: NCT00076375
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-01-21
• Study First Submitted QC: 2004-01-22
• Study First Posted: 2004-01-23
• Status Verified: 2004-04
• Study Completion: 2004-04
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (11)

National Allergy, Asthma & Urticaria Centers of Charleston, P.A.; 🇺🇸 Charleston, South Carolina, United States

nTouch Research; 🇺🇸 Washington, District of Columbia, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

ACE Research Specialists, Inc.; 🇺🇸 Nashville, Tennessee, United States

Sadick Dermatology & Aesthetic Surgery; 🇺🇸 New York, New York, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Clinical Research of Winston-Salem, Inc.; 🇺🇸 Winston Salem, North Carolina, United States

National Jewish Medical & Research Center; 🇺🇸 Denver, Colorado, United States

Medical Affliated Research Centers, Inc.; 🇺🇸 Huntsville, Alabama, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Radiant Research; 🇺🇸 Lakewood, Washington, United States