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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00432185
Date of registration: 06/02/2007
Primary sponsor: Peplin
Public title: To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
Scientific title: An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.
Date of first enrolment: February 2007
Target sample size: 117
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   Angela Smith
Affiliation:  Peplin
Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Superficial Basal Cell Carcinoma
Drug: PEP005
Primary Outcome(s)
Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring. [Time Frame: 85 days]
Secondary Outcome(s)
Efficacy (complete sBCC clearance rate and composite sBCC clearance rate) [Time Frame: 85 days]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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