Trial · NCT01926496
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
NCT01926496, Phase 4, Completed, LEO Pharma; results first posted 2020-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%. Trials, record NCT01926496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01926496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
- NCT number
- NCT01926496
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 485 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Actinic Keratosis (AK)
- Interventions
- Ingenol Mebutate Gel, 0.015%, Imiquimod Cream, 5%
- First posted
- 2013-08-21
- Last updated
- 2025-03-07
- Other registries' IDs
- eudract:2012-003112-31
- Results first posted
- 2020-07-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of SCC | 3 years | Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.\> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.\> Kaplan-Meier estimate based on time to SCC or censoring. |
| Secondary | Incidence of SCC and Other Neoplasia | 3 years | Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.\> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.\> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring. |
| Secondary | Number of Participants With Complete Clearance of AK Lesions After Last Treatment | 8-16 weeks | To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) |
| Secondary | Number of Participants With Partial Clearance of AK Lesions | 8-16 weeks | To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16) |
| Secondary | Number of Participants With Complete Clearance of AK Lesions at 12 Months | 1 year | To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of SCC | 3 years | Safety analysis set: all treated subjects | percentage of subjects | NUMBER |
| SECONDARY | Incidence of SCC and Other Neoplasia | 3 years | Safety analysis set: all treated subjects | percentage of subjects | NUMBER |
| SECONDARY | Number of Participants With Complete Clearance of AK Lesions After Last Treatment | 8-16 weeks | Full analysis set: all randomised subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Partial Clearance of AK Lesions | 8-16 weeks | Full analysis set: all randomised subjects | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Clearance of AK Lesions at 12 Months | 1 year | Full analysis set: all randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of SCC | Ingenol Mebutate | 3.1 | 95% Confidence Interval 1.4 to 6.0 | percentage of subjects | |
| Incidence of SCC | Imiquimod | 0.4 | 95% Confidence Interval 0.0 to 2.2 | percentage of subjects | |
| Incidence of SCC and Other Neoplasia | Ingenol Mebutate | 6.2 | 95% Confidence Interval 3.5 to 9.8 | percentage of subjects | |
| Incidence of SCC and Other Neoplasia | Imiquimod | 2.3 | 95% Confidence Interval 0.9 to 4.9 | percentage of subjects | |
| Number of Participants With Complete Clearance of AK Lesions After Last Treatment | Ingenol Mebutate | 168 | Participants | ||
| Number of Participants With Complete Clearance of AK Lesions After Last Treatment | Imiquimod | 192 | Participants | ||
| Number of Participants With Partial Clearance of AK Lesions | Ingenol Mebutate | 195 | Participants | ||
| Number of Participants With Partial Clearance of AK Lesions | Imiquimod | 210 | Participants | ||
| Number of Participants With Complete Clearance of AK Lesions at 12 Months | Ingenol Mebutate | 70 | Participants | ||
| Number of Participants With Complete Clearance of AK Lesions at 12 Months | Imiquimod | 108 | 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 | Ingenol Mebutate | 240 | |
| Overall Study | STARTED | Imiquimod | 245 | |
| Overall Study | COMPLETED | Ingenol Mebutate | 203 | |
| Overall Study | COMPLETED | Imiquimod | 197 | |
| Overall Study | NOT COMPLETED | Ingenol Mebutate | 37 | |
| Overall Study | NOT COMPLETED | Imiquimod | 48 |
Source ClinicalTrials.gov
Adverse events184
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 |
|---|---|---|---|---|---|---|
| other | Eye swelling | Eye disorders | Ingenol Mebutate Until Week 20 | 6 | 240 | 6 |
| other | Eye swelling | Eye disorders | Imiquimod Until Week 20 | 0 | 244 | 0 |
| other | Eye swelling | Eye disorders | Ingenol Mebutate After Week 20 | 0 | 240 | 0 |
| other | Eye swelling | Eye disorders | Imiquimod After Week 20 | 0 | 244 | 0 |
| other | Eyelid oedema | Eye disorders | Ingenol Mebutate Until Week 20 | 8 | 240 | 9 |
| other | Eyelid oedema | Eye disorders | Imiquimod Until Week 20 | 0 | 244 | 0 |
| other | Eyelid oedema | Eye disorders | Ingenol Mebutate After Week 20 | 0 | 240 | 0 |
| other | Eyelid oedema | Eye disorders | Imiquimod After Week 20 | 0 | 244 | 0 |
| other | Nausea | Gastrointestinal disorders | Ingenol Mebutate Until Week 20 | 3 | 240 | 3 |
| other | Nausea | Gastrointestinal disorders | Imiquimod Until Week 20 | 5 | 244 | 5 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ingenol Mebutate Until Week 20 | 0 | 240 |
| Total, all-cause mortality | Imiquimod Until Week 20 | 1 | 244 |
| Total, all-cause mortality | Ingenol Mebutate After Week 20 | 8 | 240 |
| Total, all-cause mortality | Imiquimod After Week 20 | 5 | 244 |
| Total, other adverse events | Ingenol Mebutate Until Week 20 | 67 | 240 |
| Total, other adverse events | Imiquimod Until Week 20 | 70 | 244 |
| Total, other adverse events | Ingenol Mebutate After Week 20 | 51 | 240 |
| Total, other adverse events | Imiquimod After Week 20 | 50 | 244 |
| Total, serious adverse events | Ingenol Mebutate Until Week 20 | 21 | 240 |
| Total, serious adverse events | Imiquimod Until Week 20 | 14 | 244 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Ingenol Mebutate vs Imiquimod: Number of Participants With Complete Clearance of AK Lesions After Last Treatment | Trial comparisons |
| Ingenol Mebutate vs Imiquimod: Number of Participants With Complete Clearance of AK Lesions at 12 Months | Trial comparisons |
| Ingenol Mebutate vs Imiquimod: Number of Participants With Partial Clearance of AK Lesions | 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/NCT01926496
GET https://conductscience.org/api/trials/v1/NCT01926496/events?page=2