Phase 3
Completed N=255
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
Actinic Keratoses
Source: ClinicalTrials.gov NCT00742391 ↗
Enrolled (actual)
255
Serious AEs
1.6%
Results posted
Mar 2012
Primary outcomePrimary: Patients With Complete Clearance of Actinic Keratosis (AKs) — 35; 6 Participants — p=<0.0001
Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Complete Clearance of Actinic Keratosis (AKs) |
35; 6 | <0.0001 sig |
| SECONDARY Patients With Partial Clearance of Actinic Keratosis (AKs) |
56; 6 | 0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00742391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.