Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329121
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2006-05-22
Brief Title:
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ
Sponsor:
Peplin
Organization:
Peplin
Study Overview
Official Title:
Multi-centre Open-label Study to Determine the Safety and Efficacy of PEP005 005 Topical Gel in Patients With Cutaneous Squamous Cell Carcinoma In Situ SCCIS Bowens Disease
Status:
COMPLETED
Status Verified Date:
2015-01
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 whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ SCCIS Bowens disease
Detailed Description:
Squamous cell carcinomas SCCs are a common skin problem largely caused by long term sun exposure Current treatments include surgery curettagedesiccation and some topical pharmaceutical therapies which are often cosmetically disfiguring Non-invasive alternative therapy for treatment of SCC 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 Ltd To date three well-controlled studies with PEP005 gel in humans have been completed In the first and second completed studies sixteen 1st study and sixty-four 2nd study patients received one or two applications of PEP005 00025 or 001 or 005 or vehicle gel to actinic keratoses In the third completed study sixty patients received two applications of PEP005 00025 or 001 or 005 or vehicle gel to superficial basal cell carcinomas Results from all studies show good tolerance and evidence of activity
The current study is designed to evaluate the efficacy and safety of two applications of 005 PEP005 gel in patients with SCCIS on the extremities trunk or face Approximately 24 patients are planned to be included from multiple Australian centers Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for 2-3 months
The current study is designed to evaluate the efficacy and safety of two applications of 005 PEP005 gel in patients with SCCIS on the extremities trunk or face Approximately 24 patients are planned to be included from multiple Australian centers Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for 2-3 months
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