Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108121
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2005-04-14
Brief Title:
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma
Sponsor:
Peplin
Organization:
Peplin
Study Overview
Official Title:
A Multi-center Randomized Double-blind Parallel-group Vehicle-controlled Study to Determine the Safety of PEP005 00025 001 and 005 Gel With Two Treatment Schedules Day 1 2 or Day 1 8 Applications to Nodular Basal Cell Carcinoma
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 topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma
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 Ltd To date only one well-controlled study with PEP005 gel in humans has been completed Sixteen patients received a single application of PEP005 001 or vehicle gel to actinic keratoses on the chest shoulders back andor arms Results show good tolerance and evidence of activity
The current study is designed to evaluate the safety of two applications of PEP005 gel in patients with nBCC nodular basal cell carcinoma on the arms shoulders chest face andor scalp testing three concentrations according to two treatment regimens Approximately 60 patients are planned to be included from multiple Australian centers
Efficacy and cosmetic outcome will be assessed and a recommended treatment regimen will be determined Assignment to treatment is random and patients and medical staff will be blinded as to the treatment
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 approximately 3 months
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 only one well-controlled study with PEP005 gel in humans has been completed Sixteen patients received a single application of PEP005 001 or vehicle gel to actinic keratoses on the chest shoulders back andor arms Results show good tolerance and evidence of activity
The current study is designed to evaluate the safety of two applications of PEP005 gel in patients with nBCC nodular basal cell carcinoma on the arms shoulders chest face andor scalp testing three concentrations according to two treatment regimens Approximately 60 patients are planned to be included from multiple Australian centers
Efficacy and cosmetic outcome will be assessed and a recommended treatment regimen will be determined Assignment to treatment is random and patients and medical staff will be blinded as to the treatment
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 approximately 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005153 | None | None | None |