Phase 3
N=203
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
Bottom Line
View on ClinicalTrials.gov: NCT00942604 ↗Enrolled (actual)
203
Serious AEs
2.0%
Results posted
Mar 2012
Primary outcome: Primary: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions — 42; 5 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PEP005 (ingenol mebutate) Gel (Drug); Vehicle gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peplin
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions |
42; 5 | 0.001 sig |
| SECONDARY Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions |
55; 7 | 0.001 sig |
Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
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 (NCT00942604). 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.