Trial Outcomes & Findings for To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis (NCT NCT02385318)
NCT ID: NCT02385318
Last Updated: 2021-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
519 participants
Primary outcome timeframe
Day 57
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Test Product
Ingenol Mebutate gel (Perrigo)
|
Reference Product
Ingenol Mebutate gel (Reference)
|
Placebo Product
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
204
|
210
|
105
|
|
Overall Study
COMPLETED
|
200
|
203
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Test Product
n=204 Participants
Ingenol Mebutate
Ingenol Mebutate (Perrigo)
|
Reference Product
n=210 Participants
Ingenol Mebutate
Ingenol Mebutate (Reference)
|
Placebo Product
n=105 Participants
Placebo gel
Placebo gel
|
Total
n=519 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.91 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 9.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
404 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
198 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
506 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
514 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 57Population: Per protocol population
Outcome measures
| Measure |
Test Product
n=168 Participants
Ingenol Mebutate
Ingenol Mebutate (Perrigo)
|
Reference Product
n=176 Participants
Ingenol Mebutate
Ingenol Mebutate (Reference)
|
Placebo Product
n=83 Participants
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
|
81 Participants
|
76 Participants
|
10 Participants
|
Adverse Events
Test Product
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Reference Product
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Product
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=204 participants at risk
Ingenol Mebutate
Ingenol Mebutate (Perrigo)
|
Reference Product
n=210 participants at risk
Ingenol Mebutate
Ingenol Mebutate (Reference)
|
Placebo Product
n=105 participants at risk
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Cardiac disorders
Sudden Death, Probable Myocardial Infarction
|
0.49%
1/204 • Number of events 1 • 57 days
|
0.00%
0/210 • 57 days
|
0.00%
0/105 • 57 days
|
|
Infections and infestations
Sepsis
|
0.49%
1/204 • Number of events 1 • 57 days
|
0.00%
0/210 • 57 days
|
0.00%
0/105 • 57 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Breast Cancer
|
0.49%
1/204 • Number of events 1 • 57 days
|
0.00%
0/210 • 57 days
|
0.00%
0/105 • 57 days
|
|
Musculoskeletal and connective tissue disorders
Worsening of Right Hip Osteoarthritis
|
0.49%
1/204 • Number of events 1 • 57 days
|
0.00%
0/210 • 57 days
|
0.00%
0/105 • 57 days
|
|
Infections and infestations
Acute Gastroenteritis/Food Poisoning
|
0.00%
0/204 • 57 days
|
0.48%
1/210 • Number of events 1 • 57 days
|
0.00%
0/105 • 57 days
|
|
Infections and infestations
Acute Sigmoid Diverticulitis/Colitis
|
0.00%
0/204 • 57 days
|
0.00%
0/210 • 57 days
|
0.95%
1/105 • Number of events 1 • 57 days
|
Other adverse events
| Measure |
Test Product
n=204 participants at risk
Ingenol Mebutate
Ingenol Mebutate (Perrigo)
|
Reference Product
n=210 participants at risk
Ingenol Mebutate
Ingenol Mebutate (Reference)
|
Placebo Product
n=105 participants at risk
Placebo gel
Placebo gel
|
|---|---|---|---|
|
General disorders
APPLICATION SITE PAIN
|
5.4%
11/204 • Number of events 11 • 57 days
|
6.7%
14/210 • Number of events 14 • 57 days
|
0.00%
0/105 • 57 days
|
|
General disorders
APPLICATION SITE Pruritus
|
3.4%
7/204 • Number of events 7 • 57 days
|
5.2%
11/210 • Number of events 11 • 57 days
|
0.00%
0/105 • 57 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER