Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432185
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2007-02-06
Brief Title:
To Determine the Maximum Tolerated Dose Level MTD of PEP005 Topical Gel in Patients With sBCC
Sponsor:
Peplin
Organization:
Peplin
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 curettagedesiccation and simple excision which are often cosmetically disfiguring Non-invasive alternative therapy for treatment of BCC lesions is thus being researched Sap from the plant Euphorbia peplus has been used for many years in Australia as a folk remedy to treat a number of skin conditions The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Opeation Pty Ltd
The proposed study follows a previously conducted 12 week study in sBCC PEP005-003 This was a two dose schedule evaluating doses up to 005 Histological clearance rate at the end of study was 71 for the 005 concentration on the Day 1 Day 2 schedule compared with 0 in the vehicle group
The proposed study aims to determine the maximum tolerated dose level MTD of PEP005 Topical Gel in patients when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up
The proposed study follows a previously conducted 12 week study in sBCC PEP005-003 This was a two dose schedule evaluating doses up to 005 Histological clearance rate at the end of study was 71 for the 005 concentration on the Day 1 Day 2 schedule compared with 0 in the vehicle group
The proposed study aims to determine the maximum tolerated dose level MTD of PEP005 Topical Gel in patients when administered either as a single application or as two applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None