Clinical trial · Interventional
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
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)
NCT00917306CI-TRIAL-00017542completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 Gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEP005 gel
- description
- PEP005 gel, 0.05% administered once daily for 2 consecutive days
- interventionNames
- Drug: PEP005 Gel
Primary outcomes (1)
- measure
- Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
- timeFrame
- 57 days
Secondary outcomes (1)
- measure
- Efficacy (complete and partial clearance of AK lesions)
- timeFrame
- 57 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.