Clinical trial · Interventional
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand
NCT00544297CI-TRIAL-00017361completedPhase 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 examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.
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 gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEP005 gel administration
- description
- 0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand
- interventionNames
- Drug: PEP005 gel
Primary outcomes (1)
- measure
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
- timeFrame
- 57 days
Secondary outcomes (1)
- measure
- The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.
- timeFrame
- 57 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients at least 18 years of age. * Post-menopausal female patients * 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand. * Written informed consent has been obtained. * Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
References
Publications (0)
Data not yet available
No reference posted for this study.