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NCT00119158 · ClinicalTrials.gov registry record · Phase 4
Combination Therapy for Atopic Dermatitis
A Phase 4 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
NCT00119158: Completed Phase 4 study, sponsored by Children's Hospital of Philadelphia.
NCT00119158 is a Phase 4 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 90 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00119158, a Phase 4 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
Study Summary
Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
Primary Outcome
Eczema Area severity index (EASI) is a composition of scores based on area of eczema involved, (0 = mild to 3 = severe) for four separate Atopic Dermatitis (AD) symptoms: erythema,infiltration ⁄population, excoriation and ichenification. Total score 0-12
Interventions
- DRUG Combination of pimecrolimus and fluticasone
- DRUG pimecrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-06 |
| Phase | Phase 4 |
What the finished NCT00119158 record still lists
NCT00119158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Combination of pimecrolimus and fluticasone is the first listed.
NCT00119158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00119158 about?
NCT00119158 is a clinical study titled "Combination Therapy for Atopic Dermatitis". Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and...
What is the current status of trial NCT00119158?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2004-10. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00119158?
The interventions under investigation include: Combination of pimecrolimus and fluticasone (DRUG), pimecrolimus (DRUG).
Who is sponsoring clinical trial NCT00119158?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00119158's enrollment target sits among peer trials
90 886th of 2000 higher than 1,088 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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