Clinical trial NCT00432185: To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Superficial Basal Cell Carcinoma
Keywords: sBCC
Topical
Dermatology
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: 1. Male or female patients at least 18 years of age.
2. A primary clinically diagnosed and histologically confirmed sBCC lesion located on the trunk which is suitable for excision the histological diagnosis should be made no more than 60 days prior to the screening visit the biopsy specimen should have removed no more that 20% of the total tumour mass
3. Ability to follow study instructions and likely to complete all study requirements.
4. Written informed consent has been obtained.
5. Agreement from the patient to allow photographs of the selected lesion to be taken and used as part of the study data package.

Primary outcomes:
measure: Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.
timeFrame: 85 days
Secondary outcomes:
measure: Efficacy (complete sBCC clearance rate and composite sBCC clearance rate)
timeFrame: 85 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Alta Dermatology
state: Arizona
city: Oceanside
country: United States
facility: Dermatology Specialists Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Clermont
country: United States
facility: Advanced Dermatology and Cosmetic Surgery
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Fridley
country: United States
facility: Minnesota Clinical Studies Center
state: Minnesota
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Goodlettsville
country: United States
facility: Rivergate Dermatology and Skin Care Center
state: Tennessee
Study officials:
affiliation: Peplin
name: Angela Smith
role: STUDY_DIRECTOR
References:
citation: Gross K. Safety and efficacy of ingenol mebutate (PEP005) gel for topical treatment of superficial basal cell carcinoma. J Am Acad Dermatol 2009; 60(3, Suppl. 1): AB141; P2928
citation: Gross K, Schmieder GJ, Tu J. Maximum Tolerated Dose and Safety of PEP005 (ingenol mebutate) Gel for Topical Treatment of Superficial Basal Cell Carcinoma. Summer Academy, American Academy of Dermatology meeting, Boston, MA, 2009. 2009: Poster no. 1902 (31 p.)