Trial · NCT01541553
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
NCT01541553, Phase 3, Completed, LEO Pharma; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp. Trials, record NCT01541553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01541553
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
- NCT number
- NCT01541553
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 367 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Actinic Keratosis
- Interventions
- Cryotherapy, Vehicle, Ingenol metabute
- First posted
- 2012-03-01
- Last updated
- 2025-03-10
- Results first posted
- 2014-03-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Clearance of AKs at Week 11 | 11 weeks | 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. |
| Secondary | Percentage Change From Baseline in Number of AKs at Week 11 | Baseline to week 11 | Percentage change from baseline in number of AKs at Week 11 |
| Secondary | Partial Clearance of AKs at Week 11 | Week 11 | Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Clearance of AKs at Week 11 | 11 weeks | participants | NUMBER | |
| SECONDARY | Percentage Change From Baseline in Number of AKs at Week 11 | Baseline to week 11 | percentage of change | MEAN | |
| SECONDARY | Partial Clearance of AKs at Week 11 | Week 11 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Clearance of AKs at Week 11 | PEP005 Gel, 0.015% | 101 | participants | ||
| Complete Clearance of AKs at Week 11 | Vehicle Gel | 80 | participants | ||
| Percentage Change From Baseline in Number of AKs at Week 11 | PEP005 Gel, 0.015% | 81.1 | Standard Deviation 31.8 | percentage of change | |
| Percentage Change From Baseline in Number of AKs at Week 11 | Vehicle Gel | 74.1 | Standard Deviation 34.4 | percentage of change | |
| Partial Clearance of AKs at Week 11 | PEP005 Gel, 0.015% | 130 | participants | ||
| Partial Clearance of AKs at Week 11 | Vehicle Gel | 109 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEP005 Gel, 0.015% | 167 | |
| Overall Study | STARTED | Vehicle Gel | 162 | |
| Overall Study | COMPLETED | PEP005 Gel, 0.015% | 155 | |
| Overall Study | COMPLETED | Vehicle Gel | 148 | |
| Overall Study | NOT COMPLETED | PEP005 Gel, 0.015% | 12 | |
| Overall Study | NOT COMPLETED | Vehicle Gel | 14 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PEP005 Gel, 0.015% | 2 | 167 | |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle Gel | 1 | 162 | |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PEP005 Gel, 0.015% | 1 | 167 | |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle Gel | 1 | 162 | |
| serious | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PEP005 Gel, 0.015% | 3 | 167 | |
| serious | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle Gel | 1 | 162 | |
| serious | Syncope | Nervous system disorders | PEP005 Gel, 0.015% | 1 | 167 | |
| serious | Syncope | Nervous system disorders | Vehicle Gel | 0 | 162 | |
| serious | Transient ischeamic | Nervous system disorders | PEP005 Gel, 0.015% | 0 | 167 | |
| serious | Transient ischeamic | Nervous system disorders | Vehicle Gel | 1 | 162 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEP005 Gel, 0.015% | ||
| Total, all-cause mortality | Vehicle Gel | ||
| Total, other adverse events | PEP005 Gel, 0.015% | 0 | 167 |
| Total, other adverse events | Vehicle Gel | 0 | 162 |
| Total, serious adverse events | PEP005 Gel, 0.015% | 7 | 167 |
| Total, serious adverse events | Vehicle Gel | 4 | 162 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PEP005 Gel, 0.015% vs Vehicle Gel: Partial Clearance of AKs at Week 11 | Trial comparisons |
| PEP005 Gel, 0.015% vs Vehicle Gel: Complete Clearance of AKs at Week 11 | Trial comparisons |
| PEP005 Gel, 0.015% vs Vehicle Gel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01541553
GET https://conductscience.org/api/trials/v1/NCT01541553/registered