NCT00076375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2004

First QC Date

January 21, 2004

Last Update Submit

June 23, 2005

Conditions

Atopic DermatitisEczema

Keywords

Atopic DermatitisEczema

Interventions

Nanocrystalline silver cream (NPI)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Medical Affliated Research Centers, Inc.

Huntsville, Alabama, 35801, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

nTouch Research

Washington D.C., District of Columbia, 20037, United States

Location

Radiant Research

West Palm Beach, Florida, 33407, United States

Location

Radiant Research

Boise, Idaho, 83704, United States

Location

Radiant Research

Overland Park, Kansas, 66215, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Sadick Dermatology & Aesthetic Surgery

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Clinical Research of Winston-Salem, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Radiant Research

Philadelphia, Pennsylvania, 19115, United States

Location

National Allergy, Asthma & Urticaria Centers of Charleston, P.A.

Charleston, South Carolina, 29407, United States

Location

Radiant Research

Greer, South Carolina, 29605, United States

Location

ACE Research Specialists, Inc.

Nashville, Tennessee, 37203, United States

Location

Radiant Research

Lakewood, Washington, 98499, United States

Location

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2004

First Posted

January 23, 2004

Study Start

November 1, 2003

Study Completion

April 1, 2004

Last Updated

June 24, 2005

Record last verified: 2004-04

Locations

US(19)