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NCT00377273 · ClinicalTrials.gov registry record · Phase 4
An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 250
- Enrollment target
NCT00377273: Completed Phase 4 study, sponsored by Sanofi.
NCT00377273 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 250 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00377273, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 250 participants
- Enrollment target
Study Summary
This study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("AKs") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with fluorouracil cream to the face.
Interventions
- DRUG fluorouracil cream 0.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2003-11 |
| Est. Completion | 2005-10 |
| Phase | Phase 4 |
What the finished NCT00377273 record still lists
NCT00377273 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which fluorouracil cream 0.5% is the first listed.
NCT00377273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00377273 about?
NCT00377273 is a clinical study titled "An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses". This study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("AKs") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to...
What is the current status of trial NCT00377273?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2003-11. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00377273?
The interventions under investigation include: fluorouracil cream 0.5% (DRUG).
Who is sponsoring clinical trial NCT00377273?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377273's enrollment target sits among peer trials
250 342nd of 2000 higher than 1,648 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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