Status:
COMPLETED
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
Lead Sponsor:
Peplin
Conditions:
Superficial Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Detailed Description
Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetic...
Eligibility Criteria
Inclusion
- Male or female patients at least 18 years of age.
- 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
- Ability to follow study instructions and likely to complete all study requirements.
- Written informed consent has been obtained.
- Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00432185
Start Date
February 1 2007
End Date
March 1 2010
Last Update
February 15 2016
Active Locations (9)
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1
Alta Dermatology
Mesa, Arizona, United States, 85206
2
Dermatology Specialists Inc.
Oceanside, California, United States, 92056
3
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
4
Colorado Medical Research Center
Denver, Colorado, United States, 80210