Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
NCT ID: NCT00659893
Last Updated: 2015-09-14
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
PHASE1
64 participants
INTERVENTIONAL
2008-04-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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1
Cohort 1 One 25 cm2 treatment area; on one arm
PEP005 Topical gel
0.05%, two day dose
2
Cohort 2 One 50cm2 contiguous treatment area; on one arm
PEP005 Topical gel
0.05%, two day dose
3
Cohort 3 Two 25cm2 treatment areas; one on each arm
PEP005 Topical gel
0.05%, two day dose
4
Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm
PEP005 Topical gel
0.05%, two day dose
5
Cohort 5 One 75cm2 contiguous treatment area; on one arm
PEP005 Topical gel
0.05%, two day dose
6
Cohort 6 Two 50cm2 contiguous treatment area; one on each arm
PEP005 Topical gel
0.05%, two day dose
7
Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm
PEP005 Topical gel
0.05%, two day dose
8
Cohort 8 One 100cm2 contiguous treatment area; on one arm
PEP005 Topical gel
0.05%, two day dose
Interventions
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PEP005 Topical gel
0.05%, two day dose
Eligibility Criteria
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Inclusion Criteria
* A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
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
MALE
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Principal Investigators
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George Schmieder, DO
Role: PRINCIPAL_INVESTIGATOR
Park Avenue Dermatology
Stephen Shumack, MD
Role: PRINCIPAL_INVESTIGATOR
St George Dermatology and Skin and Cancer Centre
Locations
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Radiant Research
Tucson, Arizona, United States
Skin Surgery Medical Group Inc.
San Diego, California, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States
Radiant Research Inc.
Pinellas Park, Florida, United States
Medaphase Inc
Newnan, Georgia, United States
Karen S. Harkaway, MD LLC
Riverside Park, New Jersey, United States
J&S Studies
College Station, Texas, United States
St George Dematology and Skin and Cancer Centre
Kogarah, Sydney, New South Wales, Australia
South East Dermatology, Belmont Specialist Centre
Carina Heights, Brisbane, Queensland, Australia
Skin and Cancer Foundation
Carlton, Melbourne, Victoria, Australia
St John of God Dermatology
Subiaco, Perth, Western Australia, Australia
Burswood Dermatology
Victoria Park, Perth, Western Australia, Australia
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 Administration
Therapeutic Goods Administration
Other Identifiers
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PEP005-022
Identifier Type: -
Identifier Source: org_study_id
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