To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
NCT ID: NCT00432185
Last Updated: 2016-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2007-02-28
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
One day treatment
PEP005
0.25% PEP005 Gel
2
Two day treatment
PEP005
0.25% PEP005 Gel
Interventions
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PEP005
0.25% PEP005 Gel
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Principal Investigators
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Angela Smith
Role: STUDY_DIRECTOR
Peplin
Locations
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Alta Dermatology
Mesa, Arizona, United States
Dermatology Specialists Inc.
Oceanside, California, United States
Skin Surgery Medical Group Inc.
San Diego, California, United States
Colorado Medical Research Center
Denver, Colorado, United States
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Minnesota Clinical Studies Center
Fridley, Minnesota, United States
Dermatology Associates of Rochester
Rochester, New York, United States
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, United States
Countries
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References
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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.)
Related Links
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Central IRB
Other Identifiers
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PEP005-009
Identifier Type: -
Identifier Source: org_study_id
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