Completed

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

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What is being tested

Data Collection

Who is being recruted

Dermatitis+7

+ Dermatitis, Atopic

+ Eczema

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorNucryst Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00076375
Principal SponsorNucryst Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicEczemaHypersensitivityHypersensitivity, ImmediateImmune System DiseasesSkin DiseasesSkin Diseases, GeneticSkin Diseases, EczematousGenetic Diseases, Inborn

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Radiant Research

Birmingham, United StatesSee the location
Suspended

Medical Affliated Research Centers, Inc.

Huntsville, United States
Suspended

National Jewish Medical & Research Center

Denver, United States
Suspended

nTouch Research

Washington, United States
Completed19 Study Centers