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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00432185
First received: February 6, 2007
Last updated: October 10, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Superficial Basal Cell Carcinoma
 Drug: PEP005
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

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

Secondary Outcome Measures:
  • Efficacy (complete sBCC clearance rate and composite sBCC clearance rate) [ Time Frame: 85 days ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: February 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
One day treatment
 Drug: PEP005
0.25% PEP005 Gel
Active Comparator: 2
Two day treatment
 Drug: PEP005
0.25% PEP005 Gel

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432185

Locations
United States, Arizona
Alta Dermatology
130 South 63rd St, Bldg 3, Suite 114, Mesa, Arizona, United States, 85206
United States, California
Dermatology Specialists Inc.
2067 West Vista Way, Suite 250 Vista, California, United States
Skin Surgery Medical Group Inc.
5222 Balboa Avenue Sixth Floor, San Diego, California, United States
United States, Colorado
Colorado Medical Research Center
950 East Harvard Avenue Suite 630, Denver, Colorado, United States
United States, Florida
Advanced Dermatology and Cosmetic Surgery
1120 Citrus Tower Blvd Suite 330, Clermont, Florida, United States, FL 34711
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
United States, Minnesota
Minnesota Clinical Studies Center
7205 University Ave, FRIDLEY, Minnesota, United States
United States, New York
Dermatology Associates of Rochester
100 White Spruce Blvd, Rochester, New York, United States, 14623
United States, Tennessee
Rivergate Dermatology and Skin Care Center
201 Bluebird Dr, Goodlettsville, Tennessee, United States
Sponsors and Collaborators
Peplin
Investigators
Study Director: Angela Smith Peplin
  More Information

Additional Information:
Central IRB  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Angela Smith, Peplin
ClinicalTrials.gov Identifier: NCT00432185     History of Changes
Other Study ID Numbers: PEP005-009
Study First Received: February 6, 2007
Last Updated: October 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Peplin:
sBCC
Topical
Dermatology

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

ClinicalTrials.gov processed this record on May 22, 2013