Trial · NCT02385318

To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

NCT02385318, Phase 3, Completed, Padagis LLC; results first posted 2021-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis. Trials, record NCT02385318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02385318

On this page

Trial

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

Title: To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
NCT number: NCT02385318
Status: Completed
Phases: Phase 3
Enrollment: 519 participants, actual
Lead sponsor: Padagis LLC
Conditions: Actinic Keratosis
Interventions: Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference), Placebo gel
First posted: 2015-03-11
Last updated: 2021-11-02
Results first posted: 2021-01-22

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Day 57

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	Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Day 57	Per protocol 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
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Test Product	81	Participants
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Reference Product	76	Participants
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator	Placebo Product	10	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Test Product	204
Overall Study	STARTED	Reference Product	210
Overall Study	STARTED	Placebo Product	105
Overall Study	COMPLETED	Test Product	200
Overall Study	COMPLETED	Reference Product	203
Overall Study	COMPLETED	Placebo Product	99
Overall Study	NOT COMPLETED	Test Product	4
Overall Study	NOT COMPLETED	Reference Product	7
Overall Study	NOT COMPLETED	Placebo Product	6

Source ClinicalTrials.gov

Adverse events24

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	APPLICATION SITE PAIN	General disorders	Test Product	11	204	11
other	APPLICATION SITE PAIN	General disorders	Reference Product	14	210	14
other	APPLICATION SITE PAIN	General disorders	Placebo Product	0	105	0
other	APPLICATION SITE Pruritus	General disorders	Test Product	7	204	7
other	APPLICATION SITE Pruritus	General disorders	Reference Product	11	210	11
other	APPLICATION SITE Pruritus	General disorders	Placebo Product	0	105	0
serious	Sudden Death, Probable Myocardial Infarction	Cardiac disorders	Test Product	1	204	1
serious	Sudden Death, Probable Myocardial Infarction	Cardiac disorders	Reference Product	0	210	0
serious	Sudden Death, Probable Myocardial Infarction	Cardiac disorders	Placebo Product	0	105	0
serious	Sepsis	Infections and infestations	Test Product	1	204	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test Product	1	204
Total, all-cause mortality	Reference Product	0	210
Total, all-cause mortality	Placebo Product	0	105
Total, other adverse events	Test Product	11	204
Total, other adverse events	Reference Product	14	210
Total, other adverse events	Placebo Product	0	105
Total, serious adverse events	Test Product	4	204
Total, serious adverse events	Reference Product	1	210
Total, serious adverse events	Placebo Product	1	105

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/NCT02385318

GET https://conductscience.org/api/trials/v1/NCT02385318/events?page=2

API reference For AI assistants