A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis
NCT ID: NCT00852137
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2009-03-31
2009-06-30
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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PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle Gel
Vehicle Gel
Vehicle Gel once daily for 2 consecutive days
Interventions
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PEP005 (ingenol mebutate) Gel, 0.05%
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle Gel
Vehicle Gel once daily for 2 consecutive days
Eligibility Criteria
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Inclusion Criteria
* Multiple actinic keratosis (AK) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm.
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 within 2 cm of the selected treatment area(s).
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Jarratt, MD
Role: PRINCIPAL_INVESTIGATOR
Derm Research, PLLC
Locations
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DermResearch, Inc.
Austin, Texas, United States
Countries
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References
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Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.
Related Links
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Food and Drug Authority
Other Identifiers
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PEP005-017
Identifier Type: -
Identifier Source: org_study_id
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