Clinical trial NCT00742391: A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Official title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.


Eligibility criteria: Inclusion Criteria:

* Must be male or female and at least 18 years of age.
* Female patients must be of:
* Non-childbearing potential;
* Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
* 4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
* 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

Primary outcomes:
measure: Patients With Complete Clearance of Actinic Keratosis (AKs)
timeFrame: 57 days
Secondary outcomes:
measure: Patients With Partial Clearance of Actinic Keratosis (AKs)
timeFrame: baseline and 57 days
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Omni Dermatology Research
state: Arizona
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Kissimmee
country: United States
facility: Advanced Dermatology and Cosmetic Research
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Ormond Beach
country: United States
facility: Advanced Dermatology & Cosmetic Surgery
state: Florida
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Centre
state: Georgia
city: Plainfield
country: United States
facility: Dermatology Center of Indiana/Indiana Clinical Trials Center
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: South Delran
country: United States
facility: Karen S. Harkaway, MD. LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Germantown
country: United States
facility: Dermatology East
state: Tennessee
city: Goodlettsville
country: United States
facility: Rivergate Dermatology and Skin Care Center
state: Tennessee
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Victoria Park
country: Australia
facility: Burswood Dermatology
state: Western Australia
Study officials:
References:
citation: Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.