Trials / Completed
CompletedNCT01541553
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 367 (actual)
- Sponsor
- LEO Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cryotherapy | Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area |
| DRUG | Vehicle | Field treatment with vehicle gel once daily for 3 consecutive days. |
| DRUG | Ingenol metabute | Field treatment with vehicle gel once daily for 3 consecutive days. |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2012-03-01
- Last updated
- 2025-03-10
- Results posted
- 2014-03-28
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01541553. Inclusion in this directory is not an endorsement.