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NCT01541553 · ClinicalTrials.gov registry record · Phase 3
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 367
- Enrollment target
NCT01541553: Completed Phase 3 study, sponsored by LEO Pharma.
NCT01541553 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 367 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01541553, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 367 participants
- Enrollment target
Study Summary
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Primary Outcome
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Interventions
- DRUG Vehicle
- PROCEDURE Cryotherapy
- DRUG Ingenol metabute
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01541553 record still lists
NCT01541553 is an interventional study that assigns participants to a tested intervention. The registered 367 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 (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT01541553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01541553 about?
NCT01541553 is a clinical study titled "A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp". The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
What is the current status of trial NCT01541553?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2012-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01541553?
The interventions under investigation include: Vehicle (DRUG), Cryotherapy (PROCEDURE), Ingenol metabute (DRUG).
Who is sponsoring clinical trial NCT01541553?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01541553's enrollment target sits among peer trials
367 998th of 2000 higher than 1,002 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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