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

June 23, 2005 updated by: Nucryst Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nucryst Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

January 21, 2004

First Submitted That Met QC Criteria

January 22, 2004

First Posted (ESTIMATE)

January 23, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32101-2-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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