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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-02 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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