Overview

To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peplin
Criteria
1. Male or female patients at least 18 years of age.

2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the
trunk which is suitable for excision the histological diagnosis should be made no more
than 60 days prior to the screening visit the biopsy specimen should have removed no
more that 20% of the total tumour mass

3. Ability to follow study instructions and likely to complete all study requirements.

4. Written informed consent has been obtained.

5. Agreement from the patient to allow photographs of the selected lesion to be taken and
used as part of the study data package.