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NCT00076375

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

Completed Phase 2 Last updated 23 June 2005
What this trial tests

Phase 2 trial testing Nanocrystalline silver cream (NPI) in Atopic Dermatitis in 180 participants. Completed in 1 April 2004.

Timeline
1 November 2003
1 April 2004

Quick facts

Lead sponsorNucryst Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment180
Start date1 November 2003
Estimated completion1 April 2004
Sites19 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Nucryst Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Atopic Dermatitis or Eczema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advanced delivery of natural bioactive compounds for atopic dermatitis: a review of polymeric conjugates and nanocarriers.
    Vyas J, Raytthatha N, Vyas P, Singh S, et al · · 2026 · PMID 41639533 · DOI 10.1007/s13659-025-00585-w

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