Actinic Keratoses
Conditions
Keywords
Peplin, Actinic keratosis, PEP005
Brief summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Interventions
two day treatment
DRUGVehicle gel
two day treatment
Sponsors
Peplin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be male or female and at least 18 years of age. * Female patients must be of: * Non-childbearing potential; * Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception. * 4 to 8 AK lesions on non-head locations.
Exclusion criteria
* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. * Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks. * Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Complete Clearance of Actinic Keratosis (AKs) | 57 days | Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Partial Clearance of Actinic Keratosis (AKs) | baseline and 57 days | Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area. |
Countries
Australia, United States
Participant flow
Recruitment details
The study period was 05 September 2008 (first patient randomized) to 23 February 2009 (last patient completed Day 57)
Participants by arm
| Arm | Count |
|---|---|
| PEP005 (Ingenol Mebutate) Gel PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days | 126 |
| Vehicle Gel Vehicle gel once daily for 2 consecutive days | 129 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | PEP005 (Ingenol Mebutate) Gel | Vehicle Gel | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 10.59 | 66.9 years STANDARD_DEVIATION 9.89 | 67.1 years STANDARD_DEVIATION 10.22 |
| Region of Enrollment Australia | 16 participants | 13 participants | 29 participants |
| Region of Enrollment United States | 110 participants | 116 participants | 226 participants |
| Sex: Female, Male Female | 40 Participants | 56 Participants | 96 Participants |
| Sex: Female, Male Male | 86 Participants | 73 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 125 | 0 / 129 |
| serious Total, serious adverse events | 1 / 125 | 3 / 129 |
Outcome results
Primary
Patients With Complete Clearance of Actinic Keratosis (AKs)
Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Time frame: 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel | Patients With Complete Clearance of Actinic Keratosis (AKs) | 35 Participants |
| Vehicle Gel | Patients With Complete Clearance of Actinic Keratosis (AKs) | 6 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Patients With Partial Clearance of Actinic Keratosis (AKs)
Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.
Time frame: baseline and 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel | Patients With Partial Clearance of Actinic Keratosis (AKs) | 56 participants |
| Vehicle Gel | Patients With Partial Clearance of Actinic Keratosis (AKs) | 6 participants |
p-value: 0.0001Cochran-Mantel-Haenszel