Clinical trial · Interventional
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses
NCT00107965CI-TRIAL-00017251completedPhase 2ClinicalTrials.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)
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: PEP005
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: PEP005
- type
- EXPERIMENTAL
- label
- 3
- interventionNames
- Drug: PEP005
- type
- PLACEBO_COMPARATOR
- label
- 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients * At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp Exclusion Criteria: * A cosmetic or therapeutic procedure: * within 10 cm of the selected AK lesions during the 3 months prior to study entry or * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study * Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy: * of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study * Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study * Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study * Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study * Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study * Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study * Females of childbearing potential
References
Publications (0)
Data not yet available
No reference posted for this study.