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NCT00121381 · ClinicalTrials.gov registry record · Phase 4
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
NCT00121381 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 400 participants.
The verdict
NCT00121381, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
Study Summary
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
Interventions
- DRUG Pimecrolimus plus topical corticosteroid (TCS)
- DRUG Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2005-05 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121381
The ClinicalTrials.gov registry entry for NCT00121381 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pimecrolimus plus topical corticosteroid (TCS) is the first listed.
NCT00121381 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121381 about?
NCT00121381 is a clinical study titled "Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis". Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of...
What is the current status of trial NCT00121381?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2005-05. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00121381?
The interventions under investigation include: Pimecrolimus plus topical corticosteroid (TCS) (DRUG), Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) (DRUG).
Who is sponsoring clinical trial NCT00121381?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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