Trial Outcomes & Findings for To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis (NCT NCT02459795)
NCT ID: NCT02459795
Last Updated: 2021-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
469 participants
Primary outcome timeframe
Baseline to 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
|
187
|
189
|
93
|
|
Overall Study
COMPLETED
|
181
|
186
|
92
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Test Product
n=187 Participants
Ingenol Mebutate (Perrigo)
Ingenol Mebutate (Perrigo)
|
Reference Product
n=189 Participants
Ingenol Mebutate (Reference)
Ingenol Mebutate (Reference)
|
Placebo Product
n=93 Participants
Placebo gel
Placebo gel
|
Total
n=469 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 10.33 • n=99 Participants
|
67.4 years
STANDARD_DEVIATION 9.78 • n=107 Participants
|
66.9 years
STANDARD_DEVIATION 10.37 • n=206 Participants
|
66.7 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
243 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
226 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
438 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
185 Participants
n=99 Participants
|
189 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
467 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 57Population: Per protocol population
Outcome measures
| Measure |
Test Product
n=150 Participants
Ingenol Mebutate (Perrigo)
Ingenol Mebutate (Perrigo)
|
Reference Product
n=160 Participants
Ingenol Mebutate (Reference)
Ingenol Mebutate (Reference)
|
Placebo Product
n=75 Participants
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions
|
71 Participants
|
71 Participants
|
9 Participants
|
Adverse Events
Test Product
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Reference Product
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo Product
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=187 participants at risk
Ingenol Mebutate (Perrigo)
Ingenol Mebutate (Perrigo)
|
Reference Product
n=189 participants at risk
Ingenol Mebutate (Reference)
Ingenol Mebutate (Reference)
|
Placebo Product
n=93 participants at risk
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Malignant Melanoma
|
0.53%
1/187 • Number of events 1 • Day 1 to 57
|
0.00%
0/189 • Day 1 to 57
|
0.00%
0/93 • Day 1 to 57
|
|
Cardiac disorders
Acute Congestive Heart Failure
|
0.00%
0/187 • Day 1 to 57
|
0.53%
1/189 • Number of events 1 • Day 1 to 57
|
0.00%
0/93 • Day 1 to 57
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/187 • Day 1 to 57
|
0.53%
1/189 • Number of events 1 • Day 1 to 57
|
0.00%
0/93 • Day 1 to 57
|
|
Infections and infestations
Group B Streptococcus Wound Infection
|
0.00%
0/187 • Day 1 to 57
|
0.00%
0/189 • Day 1 to 57
|
1.1%
1/93 • Number of events 1 • Day 1 to 57
|
Other adverse events
| Measure |
Test Product
n=187 participants at risk
Ingenol Mebutate (Perrigo)
Ingenol Mebutate (Perrigo)
|
Reference Product
n=189 participants at risk
Ingenol Mebutate (Reference)
Ingenol Mebutate (Reference)
|
Placebo Product
n=93 participants at risk
Placebo gel
Placebo gel
|
|---|---|---|---|
|
General disorders
Application site pain
|
10.2%
19/187 • Number of events 19 • Day 1 to 57
|
11.1%
21/189 • Number of events 21 • Day 1 to 57
|
0.00%
0/93 • Day 1 to 57
|
|
General disorders
Application site Pruritus
|
10.7%
20/187 • Number of events 20 • Day 1 to 57
|
12.2%
23/189 • Number of events 23 • Day 1 to 57
|
1.1%
1/93 • Number of events 1 • Day 1 to 57
|
|
Nervous system disorders
Headache
|
2.7%
5/187 • Number of events 5 • Day 1 to 57
|
3.2%
6/189 • Number of events 6 • Day 1 to 57
|
5.4%
5/93 • Number of events 5 • Day 1 to 57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER