To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432185
Recruitment Status : Completed
First Posted : February 7, 2007
Last Update Posted : February 15, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Superficial Basal Cell Carcinoma Drug: PEP005 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
One day treatment
Drug: PEP005
0.25% PEP005 Gel

Active Comparator: 2
Two day treatment
Drug: PEP005
0.25% PEP005 Gel

Primary Outcome Measures :
  1. Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring. [ Time Frame: 85 days ]

Secondary Outcome Measures :
  1. Efficacy (complete sBCC clearance rate and composite sBCC clearance rate) [ Time Frame: 85 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432185

United States, Arizona
Alta Dermatology
Mesa, Arizona, United States, 85206
United States, California
Dermatology Specialists Inc.
Oceanside, California, United States, 92056
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
United States, Colorado
Colorado Medical Research Center
Denver, Colorado, United States, 80210
United States, Florida
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, United States, 34711
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
United States, Minnesota
Minnesota Clinical Studies Center
Fridley, Minnesota, United States, 55421
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Tennessee
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, United States, 37072
Sponsors and Collaborators
Study Director: Angela Smith Peplin

Additional Information:
Publications of Results:
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
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.)

Responsible Party: Peplin Identifier: NCT00432185     History of Changes
Other Study ID Numbers: PEP005-009
First Posted: February 7, 2007    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: January 2016

Keywords provided by Peplin:

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell