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 |
|---|---|---|
| Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | 57 days | Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | 57 days | Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area |
Countries
United States
Participant flow
Recruitment details
The study period was 22 July 2009 (first patient randomized) to 14 October 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 | 100 |
| Vehicle Gel Vehicle gel once daily for 2 consecutive days | 103 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Patient relocation | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | PEP005 (Ingenol Mebutate) Gel | Vehicle Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 52 Participants | 51 Participants | 103 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 52 Participants | 100 Participants |
| Region of Enrollment United States | 100 participants | 103 participants | 203 participants |
| Sex: Female, Male Female | 41 Participants | 35 Participants | 76 Participants |
| Sex: Female, Male Male | 59 Participants | 68 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 100 | 1 / 103 |
| serious Total, serious adverse events | 2 / 100 | 2 / 103 |
Outcome results
Primary
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Time frame: 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel | Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | 42 participants |
| Vehicle Gel | Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | 5 participants |
p-value: 0.001Cochran-Mantel-Haenszel
Secondary
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
Time frame: 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel | Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | 55 participants |
| Vehicle Gel | Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | 7 participants |
p-value: 0.001Cochran-Mantel-Haenszel