Clinical trial · Interventional
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)
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063CI-TRIAL-00017494completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 Topical Gel | Drug | — | UNRESOLVED |
| Vehicle gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PEP005 Topical Gel
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: PEP005 Topical Gel
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Drug: PEP005 Topical Gel
- type
- PLACEBO_COMPARATOR
- label
- 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.