Phase 3
Completed N=269
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)
Source: ClinicalTrials.gov NCT00916006 ↗Enrolled (actual)
269
Serious AEs
1.5%
Results posted
Mar 2012
Primary outcomePrimary: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. — 50; 3 participants — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. |
50; 3 | 0.001 sig |
| SECONDARY Patients With Partial Clearance of Actinic Keratosis (AK) |
81; 9 | 0.001 sig |
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 (NCT00916006). 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.