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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-04-30

Brief Summary

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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

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Conditions

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Atopic Dermatitis Eczema

Keywords

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nanocrystalline silver cream (NPI)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Review additional registry numbers or institutional identifiers associated with this trial.

32101-2-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Nanocrystalline silver cream (NPI)

Eligibility Criteria

Inclusion Criteria

Sponsors

Nucryst Pharmaceuticals

Locations

Radiant Research

Medical Affliated Research Centers, Inc.

National Jewish Medical & Research Center

nTouch Research

Radiant Research

Radiant Research

Radiant Research

Radiant Research

Sadick Dermatology & Aesthetic Surgery

Mount Sinai School of Medicine

Clinical Research of Winston-Salem, Inc.

University Hospitals of Cleveland

Radiant Research

Oregon Health & Science University

Radiant Research

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

Radiant Research

ACE Research Specialists, Inc.

Radiant Research

Countries

Related Links

Other Identifiers

32101-2-01