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Sponsored by: |
Peplin |
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Information provided by: | Peplin |
ClinicalTrials.gov Identifier: | NCT00432185 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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. |
Estimated Enrollment: | 58 |
Study Start Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, Arizona | |
Alta Dermatology | Recruiting |
130 South 63rd St, Bldg 3, Suite 114, Mesa, Arizona, United States, 85206 | |
Contact: Andrew Racette, DO 480-981-2888 DrDerm@gmail.com | |
Principal Investigator: Stephen Kessler, DO | |
United States, California | |
Dermatology Specialists Inc. | Recruiting |
2067 West Vista Way, Suite 250 Vista, California, United States | |
Contact: Jessica Gallaspy 760-724-7171 research@dermspec.com | |
Principal Investigator: Ruth Gilboa, M.D | |
Skin Surgery Medical Group Inc. | Recruiting |
5222 Balboa Avenue Sixth Floor, San Diego, California, United States | |
Contact: Alisa Schweikl 858-292-8641 clinical@skinsurgerymed.com | |
Principal Investigator: Kenneth Gross, M.D | |
United States, Colorado | |
Colorado Medical Research Center | Recruiting |
950 East Harvard Avenue Suite 630, Denver, Colorado, United States | |
Contact: Thomas Swinehart 303-744-1202 cmrc@pcisys.net | |
Principal Investigator: James Swinehart, M.D | |
United States, Florida | |
Advanced Dermatology and Cosmetic Surgery | Recruiting |
1120 Citrus Tower Blvd Suite 330, Clermont, Florida, United States, FL 34711 | |
Contact: Theresa Bond 352-241-4298 tbond@leavittmgt.com | |
Contact: Joseph Douin 407 694 0345 jdouin@leavittmgt.com | |
Principal Investigator: Michael Bond, MD | |
Park Avenue Dermatology | Recruiting |
Orange Park, Florida, United States, 32073 | |
Contact: Heather Ford 904-541-0315 ext 222 hford@parkavedermatology.com | |
Principal Investigator: George Schmieder, MD | |
United States, Minnesota | |
Minnesota Clinical Studies Center | Recruiting |
7205 University Ave, FRIDLEY, Minnesota, United States | |
Contact: Dawn Snow 763-571-4000 snow@associatedskincare.com | |
Principal Investigator: Steven Kempers, M.D | |
United States, New York | |
Dermatology Associates of Rochester | Recruiting |
100 White Spruce Blvd, Rochester, New York, United States, 14623 | |
Contact: Denise Forster 585-272-0700 dforster@skinsearch.org | |
Principal Investigator: John Tu, M.D | |
United States, Tennessee | |
Rivergate Dermatology and Skin Care Center | Recruiting |
201 Bluebird Dr, Goodlettsville, Tennessee, United States | |
Contact: Janet Greer 615-859-7546 jgreer@rivderm.com | |
Principal Investigator: Keith Loven, M.D |
Study Director: | Angela Smith | Peplin |
Study ID Numbers: | PEP005-009 |
Study First Received: | February 6, 2007 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00432185 |
Health Authority: | United States: Food and Drug Administration |
sBCC Topical Dermatology |
Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell |