Clinical trial NCT00076375: Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Eczema
Keywords: Atopic Dermatitis
Eczema
Lead sponsor: Nucryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-01-23
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Huntsville
country: United States
facility: Medical Affliated Research Centers, Inc.
state: Alabama
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Washington
country: United States
facility: nTouch Research
state: District of Columbia
city: West Palm Beach
country: United States
facility: Radiant Research
state: Florida
city: Boise
country: United States
facility: Radiant Research
state: Idaho
city: Overland Park
country: United States
facility: Radiant Research
state: Kansas
city: St. Louis
country: United States
facility: Radiant Research
state: Missouri
city: New York
country: United States
facility: Sadick Dermatology & Aesthetic Surgery
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Winston Salem
country: United States
facility: Clinical Research of Winston-Salem, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma & Urticaria Centers of Charleston, P.A.
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Nashville
country: United States
facility: ACE Research Specialists, Inc.
state: Tennessee
city: Lakewood
country: United States
facility: Radiant Research
state: Washington
Study officials:
References: