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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: Completed Phase 4 study of Atopic Dermatitis, sponsored by Ceragenix Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00460083 record still lists
NCT00460083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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.
Where NCT00460083's enrollment target sits among peer trials
35 117th of 150 higher than 33 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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