Actinic Keratosis
Conditions
Keywords
Peplin, Actinic keratosis, PEP005
Brief summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Interventions
DRUGPEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days
DRUGVehicle Gel
once daily for 3 consecutive days
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
* Patient is male or female and at least 18 years of age * Female patients must be of either: * Non-childbearing potential, post-menopausal * Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy
Exclusion criteria
* Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance of Actinic Keratoses (AK) Lesions | baseline and 57 days | Complete clearance of the treatment field |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial Clearance of Actinic Keratoses (AK) | baseline and 57 days | Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area |
Countries
Australia, United States
Participant flow
Recruitment details
Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.
Participants by arm
| Arm | Count |
|---|---|
| PEP005 (Ingenol Mebutate) Gel, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days | 142 |
| Vehicle Gel Vehicle gel once daily for 3 consecutive days | 136 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 69 Participants | 73 Participants | 142 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 63 Participants | 136 Participants |
| Region of Enrollment Australia | 11 participants | 12 participants | 23 participants |
| Region of Enrollment United States | 131 participants | 124 participants | 255 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 117 Participants | 112 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 142 | 1 / 136 |
| serious Total, serious adverse events | 1 / 142 | 0 / 136 |
Outcome results
Primary
Complete Clearance of Actinic Keratoses (AK) Lesions
Complete clearance of the treatment field
Time frame: baseline and 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel, 0.015% | Complete Clearance of Actinic Keratoses (AK) Lesions | 67 participants |
| Vehicle Gel | Complete Clearance of Actinic Keratoses (AK) Lesions | 7 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Partial Clearance of Actinic Keratoses (AK)
Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area
Time frame: baseline and 57 days
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEP005 (Ingenol Mebutate) Gel, 0.015% | Partial Clearance of Actinic Keratoses (AK) | 96 participants |
| Vehicle Gel | Partial Clearance of Actinic Keratoses (AK) | 11 participants |
p-value: <0.001Cochran-Mantel-Haenszel