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 Gel
0.015%, three day treatment
DRUGVehicle gel
Vehicle gel, three 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
* 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 |
|---|---|---|
| Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | 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 (AK) | baseline and 57 days | Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area |
Countries
Australia, United States
Participant flow
Recruitment details
Study PEP005-016 was conducted at 21 study centers in the United States and Australia. A total of 269 patients were randomized. Patient screening was started on 01 June 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 10 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 | 135 |
| Vehicle Vehicle gel once daily for 3 consecutive days | 134 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 64 Participants | 57 Participants | 121 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 77 Participants | 148 Participants |
| Region of Enrollment Australia | 10 participants | 8 participants | 18 participants |
| Region of Enrollment United States | 125 participants | 126 participants | 251 participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 116 Participants | 120 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 132 | 3 / 135 |
| serious Total, serious adverse events | 2 / 132 | 2 / 135 |
Outcome results
Primary
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
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 (AK) Lesions. | 50 participants |
| Vehicle Gel | Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. | 3 participants |
p-value: 0.001Cochran-Mantel-Haenszel
Secondary
Patients With Partial Clearance of Actinic Keratosis (AK)
Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (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 | Patients With Partial Clearance of Actinic Keratosis (AK) | 81 participants |
| Vehicle Gel | Patients With Partial Clearance of Actinic Keratosis (AK) | 9 participants |
p-value: 0.001Cochran-Mantel-Haenszel