A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT ID: NCT00700063
Last Updated: 2015-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
265 participants
INTERVENTIONAL
2008-06-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PEP005 Topical Gel
0.005%, two days treatment
2
PEP005 Topical Gel
0.01%, two days treatment
3
PEP005 Topical Gel
0.015%, two days treatment
4
Vehicle gel
two days treatment
5
PEP005 Topical Gel
0.005%, three days treatment
6
PEP005 Topical Gel
0.01%, three days treatment
7
PEP005 Topical Gel
0.015%, three days treatment
8
Vehicle gel
three days treatment
Interventions
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PEP005 Topical Gel
0.005%, two days treatment
PEP005 Topical Gel
0.01%, two days treatment
PEP005 Topical Gel
0.015%, two days treatment
Vehicle gel
two days treatment
PEP005 Topical Gel
0.005%, three days treatment
PEP005 Topical Gel
0.01%, three days treatment
PEP005 Topical Gel
0.015%, three days treatment
Vehicle gel
three days treatment
Eligibility Criteria
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Inclusion Criteria
* Female patients must be of
* Non-childbearing potential;
* Childbearing potential, provided negative pregnancy test and using effective contraception
* 4 to 8 AK lesions on the face or scalp
Exclusion Criteria
* Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
* Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy:
within 8 weeks and 2 cm of treatment area
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Locations
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Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Dermatology Research of Arkansas
Little Rock, Arkansas, United States
Koppel Dermatology
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrated Research Group Inc
Riverside, California, United States
Skin Surgery Medical Group Inc
San Diego, California, United States
470 Castro St Suite 202-204
San Francisco, California, United States
Solano Clinical Research
Vallejo, California, United States
Dermatology Specialists Inc
Vista, California, United States
Spencer Derm and Skin Surgery Center
St. Petersburg, Florida, United States
Northwest Clinical Trial
Boise, Idaho, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Christie Clinic
Champaign, Illinois, United States
South Bend Clinic
South Bend, Indiana, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
TKL Research, Inc.
Paramus, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Oregon Medical Research Center
Portland, Oregon, United States
Philadelphia Institute of Dermatology
Philadelphia, Pennsylvania, United States
Dermatology Research Associates
Nashville, Tennessee, United States
DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120,
Austin, Texas, United States
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology Associates of Tyler
Tyler, Texas, United States
Southderm Pty Ltd
Kogarah, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Siller Medical
Brisbane, Queensland, Australia
Countries
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Related Links
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Food and Drug Authority
Therapeutic Goods Administration
Other Identifiers
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PEP005-015
Identifier Type: -
Identifier Source: org_study_id
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