NCT00329121

Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ

Multi-centre, Open-label Study to Determine the Safety and Efficacy of PEP005 0.05% Topical Gel in Patients With Cutaneous Squamous Cell Carcinoma In Situ (SCCIS, Bowen's Disease)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Peplin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, Bowen's disease).

Detailed description

Squamous cell carcinomas (SCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation 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 0.0025% or 0.01% or 0.05% or vehicle gel to actinic keratoses. In the third completed study, sixty patients received two applications of PEP005 0.0025% or 0.01% or 0.05% 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 0.05% 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.

Conditions

• Carcinoma, Squamous Cell

Interventions

Type	Name	Description
DRUG	PEP005

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-05-24
• Last updated: 2015-01-19

Locations

3 sites across 1 country: Australia