Trial · NCT02361216

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

NCT02361216, Phase 3, Completed, LEO Pharma; results first posted 2018-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest. Trials, record NCT02361216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02361216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT number: NCT02361216
Status: Completed
Phases: Phase 3
Enrollment: 729 participants, actual
Lead sponsor: LEO Pharma
Conditions: Actinic Keratosis
Interventions: Ingenol Mebutate, Vehicle
First posted: 2015-02-11
Last updated: 2025-03-10
Results first posted: 2018-10-03

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)	8 weeks	Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
Secondary	Percentage of Participants With Partial Clearance at Week 8	8 weeks	Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Secondary	Percentage of Participants With Partial Clearance at Week 4	4 weeks	Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Secondary	Percent Reduction From Baseline in AK Count	8 weeks	Percent reduction in AK count in the selected treatment area at Week 8

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)	8 weeks	Of the 729 subjects randomised to treatment, 4 did not receive treatment. These 4 subjects (3 subjects in active treatment group and 1 in vehicle group) were excluded from the Full Analysis Set (FAS), which consisted of 725 subjects (549 subjects in active treatment group and 176 in corresponding vehicle group). AKclear100 is based on the FAS	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Partial Clearance at Week 8	8 weeks	AKclear75 at Week 8 is based on the full analysis set (FAS)	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Partial Clearance at Week 4	4 weeks	AKclear75 at Week 4 is based on the full analysis set (FAS)	percentage of participants	NUMBER
SECONDARY	Percent Reduction From Baseline in AK Count	8 weeks	Percent reduction in AK count is based on the full analysis set (FAS)	percentage reduction of AK count	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)	Ingenol Mebutate Gel	21.4		percentage of participants
Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)	Vehicle	3.4		percentage of participants
Percentage of Participants With Partial Clearance at Week 8	Ingenol Mebutate Gel	59.4		percentage of participants
Percentage of Participants With Partial Clearance at Week 8	Vehicle	8.9		percentage of participants
Percentage of Participants With Partial Clearance at Week 4	Ingenol Mebutate Gel	59.8		percentage of participants
Percentage of Participants With Partial Clearance at Week 4	Vehicle	9.2		percentage of participants
Percent Reduction From Baseline in AK Count	Ingenol Mebutate Gel	75.7	95% Confidence Interval 73.9 to 77.3	percentage reduction of AK count
Percent Reduction From Baseline in AK Count	Vehicle Gel	12.7	95% Confidence Interval 3.0 to 21.4	percentage reduction of AK count

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
3 Day Treatment and 8 Week Follow/up	STARTED	Ingenol Mebutate Gel	552
3 Day Treatment and 8 Week Follow/up	STARTED	Vehicle Gel	177
3 Day Treatment and 8 Week Follow/up	COMPLETED	Ingenol Mebutate Gel	541
3 Day Treatment and 8 Week Follow/up	COMPLETED	Vehicle Gel	158
3 Day Treatment and 8 Week Follow/up	NOT COMPLETED	Ingenol Mebutate Gel	11
3 Day Treatment and 8 Week Follow/up	NOT COMPLETED	Vehicle Gel	19
12-month Follow-up	STARTED	Ingenol Mebutate Gel	541
12-month Follow-up	STARTED	Vehicle Gel	157
12-month Follow-up	COMPLETED	Ingenol Mebutate Gel	489
12-month Follow-up	COMPLETED	Vehicle Gel	130

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events36

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
other	Application Site Pain	General disorders	Ingenol Mebutate Gel	350	549
other	Application Site Pain	General disorders	Vehicle	4	176
other	Application Site Pruritus	General disorders	Ingenol Mebutate Gel	203	549
other	Application Site Pruritus	General disorders	Vehicle	7	176
other	Application Site Discomfort	General disorders	Ingenol Mebutate Gel	28	549
other	Application Site Discomfort	General disorders	Vehicle	2	176
other	application site parasthesia	General disorders	Ingenol Mebutate Gel	14	549
other	application site parasthesia	General disorders	Vehicle	2	176
other	headache	Nervous system disorders	Ingenol Mebutate Gel	22	549
other	headache	Nervous system disorders	Vehicle	4	176

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ingenol Mebutate Gel	0	549
Total, all-cause mortality	Vehicle	0	176
Total, other adverse events	Ingenol Mebutate Gel	394	549
Total, other adverse events	Vehicle	18	176
Total, serious adverse events	Ingenol Mebutate Gel	8	549
Total, serious adverse events	Vehicle	2	176

Source ClinicalTrials.gov

Papers0

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ingenol Mebutate Gel vs Vehicle: deaths from any cause	Trial comparisons
Ingenol Mebutate Gel vs Vehicle: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02361216

GET https://conductscience.org/api/trials/v1/NCT02361216/events?page=2

API reference For AI assistants