Phase 2
Completed N=265
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Source: ClinicalTrials.gov NCT00700063 ↗Enrolled (actual)
265
Serious AEs
0.8%
Results posted
Aug 2012
Primary outcomePrimary: Incidence of AEs Recorded Throughout the Study — 12; 12; 8; 11 participants
Summary
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of AEs Recorded Throughout the Study |
12; 12; 8; 11; 11; 14 | — |
| PRIMARY Incidence of SAE Recorded Throughout the Study |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Incidence Rate and Severity of LSRs Following Study Medication Application |
0.8; 1.1; 0.8; 1.3; 1.4; 1.1 | — |
| PRIMARY Incidence of Hyperpigmentation Following Study Medication Application |
13; 13; 7; 6; 8; 11 | — |
| PRIMARY Incidence of Hypopigmentation Following Study Medication Application |
4; 6; 6; 6; 9; 9 | — |
| PRIMARY Incidence of Scarring Following Study Medication Application |
1; 1; 1; 1; 5; 1 | — |
| PRIMARY Complete Clearance Rate of AK Lesions; |
5; 10; 12; 0; 11; 6 | — |
| SECONDARY Efficacy (Clearance of AK Lesions) Partial Clearance Rate |
11; 17; 17; 3; 14; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Must be male or female
- Female patients must be of
- Non-childbearing potential;
- Childbearing potential, provided negative pregnancy test and using effective contraception
- 4 to 8 AK lesions on the face or scalp
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 (NCT00700063). 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.