NCT00917306CompletedPhase 3
A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Peplin11 sites in 2 countries102 target enrollmentStarted: June 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 102
- Locations
- 11
- Primary Endpoint
- Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Study Overview
Brief Summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is male or female and at least 18 years of age.
- •Female patient must be of either:
- •Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
- •Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy
- •Exclusion Criteria
- •Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
- •Treatment with immunomodulators, 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.
Exclusion Criteria
- Not provided
Arms & Interventions
PEP005 gel
Experimental
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Intervention: PEP005 Gel (Drug)
Outcomes
Primary Outcomes
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Time Frame: 57 days
Secondary Outcomes
- Efficacy (complete and partial clearance of AK lesions)(57 days)
Investigators
Study Sites (11)
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