Clinical trial · Interventional
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
NCT00742391CI-TRIAL-00017024completedPhase 3Results postedClinicalTrials.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 purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
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 Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 (ingenol mebutate) Gel | Drug | — | UNRESOLVED |
| Vehicle gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- PEP005 (ingenol mebutate) Gel
- interventionNames
- Drug: PEP005 (ingenol mebutate) Gel
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Vehicle gel
- interventionNames
- Drug: Vehicle gel
Primary outcomes (1)
- measure
- Patients With Complete Clearance of Actinic Keratosis (AKs)
- timeFrame
- 57 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170. PMID 22417254