A Phase 2 interventional study of PEP005 in Superficial Basal Cell Carcinoma, sponsored by Peplin. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-15.
Sponsored by Peplin (part of LEO Pharma) · Phase 2, Interventional, and Treatment
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
Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation 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 0.05%. Histological clearance rate at the end of study was 71% for the 0.05% 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.
Peplin is the lead sponsor of 29 studies on the registry; none are open to participants now.
First submitted before Peplin became part of LEO Pharma.
Counted across the registry records on this site, refreshed daily.
One day treatment
Drug: PEP005
Two day treatment
Drug: PEP005
0.25% PEP005 Gel
Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.
Time frame: 85 days
Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)
Time frame: 85 days
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ingenol mebutate