Phase 3
N=278
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT00915551 ↗Enrolled (actual)
278
Serious AEs
0.4%
Results posted
Mar 2012
Primary outcome: Primary: Complete Clearance of Actinic Keratoses (AK) Lesions — 67; 7 participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PEP005 (Ingenol Mebutate) gel, 0.015% (Drug); Vehicle Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peplin
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance of Actinic Keratoses (AK) Lesions |
67; 7 | <0.001 sig |
| SECONDARY Partial Clearance of Actinic Keratoses (AK) |
96; 11 | <0.001 sig |
Summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Eligibility Criteria
Inclusion Criteria
- Patient is male or female and at least 18 years of age
- Female patients must be of either:
- Non-childbearing potential, post-menopausal
- Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy
Exclusion Criteria
- Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
Data sourced from ClinicalTrials.gov (NCT00915551). 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.