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NCT02616601 · ClinicalTrials.gov registry record · Phase 3
Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 422
- Enrollment target
NCT02616601: Completed Phase 3 study, sponsored by Actavis.
NCT02616601 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 422 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02616601, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 422 participants
- Enrollment target
Study Summary
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Primary Outcome
Percentage of participants with treatment success (complete clearance) at Week 6 (4 weeks after completion of 2 weeks of treatment). Complete clearance was defined as having no (zero) clinically visible actinic keratoses (AK) lesions in the treatment area at the Week 6/End Of Study visit. All AK lesions (baseline and new lesions) independent of size within the treatment area were treated and included in the efficacy lesion count.
Interventions
- DRUG Vehicle Cream
- DRUG Generic Fluorouracil Cream
- DRUG Carac® (Fluorouracil) Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2015-02-27 |
| Est. Completion | 2015-09-17 |
| Phase | Phase 3 |
What the finished NCT02616601 record still lists
NCT02616601 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle Cream is the first listed.
NCT02616601 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02616601 about?
NCT02616601 is a clinical study titled "Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis". This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
What is the current status of trial NCT02616601?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2015-02-27. Estimated completion is 2015-09-17.
What interventions are being tested in trial NCT02616601?
The interventions under investigation include: Vehicle Cream (DRUG), Generic Fluorouracil Cream (DRUG), Carac® (Fluorouracil) Cream (DRUG).
Who is sponsoring clinical trial NCT02616601?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02616601's enrollment target sits among peer trials
422 886th of 2000 higher than 1,111 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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