Trial · NCT03200912

An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

NCT03200912, Phase 3, Completed, Actavis Inc.; results first posted 2020-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis. Trials, record NCT03200912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03200912

On this page

Trial

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

Title: An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
NCT number: NCT03200912
Status: Completed
Phases: Phase 3
Enrollment: 507 participants, actual
Lead sponsor: Actavis Inc.
Conditions: ACTINIC KERATOSIS
Interventions: Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam
First posted: 2017-06-27
Last updated: 2020-01-14
Results first posted: 2020-01-14

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Complete Clearance of AK Lesions	57 days	Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Clearance of AK Lesions	57 days	AK Complete Clearance Rate at Day 57 (PP population)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Units
Complete Clearance of AK Lesions	Generic Ingenol Mebutate	45	Participants
Complete Clearance of AK Lesions	Picato (Ingenol Mebutate)	44	Participants
Complete Clearance of AK Lesions	Vehicle Gel	7	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Generic Ingenol Mebutate	170
Overall Study	STARTED	Picato (Ingenol Mebutate)	169
Overall Study	STARTED	Vehicle Gel	168
Overall Study	COMPLETED	Generic Ingenol Mebutate	166
Overall Study	COMPLETED	Picato (Ingenol Mebutate)	166
Overall Study	COMPLETED	Vehicle Gel	164
Overall Study	NOT COMPLETED	Generic Ingenol Mebutate	4
Overall Study	NOT COMPLETED	Picato (Ingenol Mebutate)	3
Overall Study	NOT COMPLETED	Vehicle Gel	4

Source ClinicalTrials.gov

Adverse events144

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	Atrial fibrillation	Cardiac disorders	Generic Ingenol Mebutate	1	170
other	Atrial fibrillation	Cardiac disorders	Picato (Ingenol Mebutate)	0	169
other	Atrial fibrillation	Cardiac disorders	Vehicle Gel	0	168
other	Conjunctival hyperaemia	Eye disorders	Generic Ingenol Mebutate	0	170
other	Conjunctival hyperaemia	Eye disorders	Picato (Ingenol Mebutate)	0	169
other	Conjunctival hyperaemia	Eye disorders	Vehicle Gel	1	168
other	Eye irritation	Eye disorders	Generic Ingenol Mebutate	0	170
other	Eye irritation	Eye disorders	Picato (Ingenol Mebutate)	1	169
other	Eye irritation	Eye disorders	Vehicle Gel	0	168
other	Eye swelling	Eye disorders	Generic Ingenol Mebutate	0	170

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Generic Ingenol Mebutate	29	170
Total, all-cause mortality	Picato (Ingenol Mebutate)	29	169
Total, all-cause mortality	Vehicle Gel	24	168
Total, other adverse events	Generic Ingenol Mebutate	29	170
Total, other adverse events	Picato (Ingenol Mebutate)	29	169
Total, other adverse events	Vehicle Gel	24	168
Total, serious adverse events	Generic Ingenol Mebutate	2	170
Total, serious adverse events	Picato (Ingenol Mebutate)	0	169
Total, serious adverse events	Vehicle Gel	2	168

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 comparisons0

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

None in this release.

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/NCT03200912

GET https://conductscience.org/api/trials/v1/NCT03200912/events?page=2

API reference For AI assistants