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NCT00546000 · ClinicalTrials.gov registry record · Phase 4
Cutivate Lotion HPA Axis Pediatric Study
A Phase 4 study, sponsored by Fougera Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00546000: Completed Phase 4 study, sponsored by Fougera Pharmaceuticals.
NCT00546000 is a Phase 4 study that has completed, run by Fougera Pharmaceuticals. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546000, a Phase 4 study, has completed, sponsored by Fougera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
Primary Outcome
The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
Interventions
- DRUG Fluticasone propionate 0.05% lotion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00546000 record still lists
NCT00546000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluticasone propionate 0.05% lotion is the first listed.
NCT00546000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00546000 about?
NCT00546000 is a clinical study titled "Cutivate Lotion HPA Axis Pediatric Study". A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
What is the current status of trial NCT00546000?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2007-07. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00546000?
The interventions under investigation include: Fluticasone propionate 0.05% lotion (DRUG).
Who is sponsoring clinical trial NCT00546000?
This trial is sponsored by Fougera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00546000's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 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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