Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00460083 · ClinicalTrials.gov registry record · Phase 4

Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

A Phase 4 study of Atopic Dermatitis, sponsored by Ceragenix Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
35
Enrollment target
2
Study locations

NCT00460083 is a Phase 4 study of Atopic Dermatitis that has completed, run by Ceragenix Pharmaceuticals. The registered enrollment target is 35 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00460083, a Phase 4 study of Atopic Dermatitis, has completed, sponsored by Ceragenix Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
35 participants
Enrollment target
2
Study locations

Study Summary

Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.

Conditions Studied

Interventions

  • DRUG Elidel(R) (pimecrolimus 1%)
  • DEVICE EpiCeram(R) -ceramide based barrier repair cream

Study Locations (2)

California

  • UCSD - San Diego

Oregon

  • OHSU - Portland

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2007-04
Est. Completion 2008-02
Phase Phase 4

Sponsor

Ceragenix Pharmaceuticals

1 total trials

What the Registry Record Tells You About NCT00460083

The ClinicalTrials.gov registry entry for NCT00460083 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (94% lower). The listed sponsor is Ceragenix Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Elidel(R) (pimecrolimus 1%) is the first listed.

NCT00460083 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Oregon.

Frequently Asked Questions

What is clinical trial NCT00460083 about?

NCT00460083 is a clinical study titled "Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis". Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to ...

What is the current status of trial NCT00460083?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2007-04. Estimated completion is 2008-02.

What conditions does trial NCT00460083 study?

This clinical trial studies the following conditions: Atopic Dermatitis.

What interventions are being tested in trial NCT00460083?

The interventions under investigation include: Elidel(R) (pimecrolimus 1%) (DRUG), EpiCeram(R) -ceramide based barrier repair cream (DEVICE).

Who is sponsoring clinical trial NCT00460083?

This trial is sponsored by Ceragenix Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00460083 being conducted?

This trial has 2 study locations across California, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Atopic Dermatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.