Clinical trial NCT00942604: 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-Ib)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 203
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: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
timeFrame: 57 days
Secondary outcomes:
measure: Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
timeFrame: 57 days
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc.
state: California
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Henderson
country: United States
facility: Karl G. Heine Dermatology
state: Nevada
city: Cincinnati
country: United States
facility: Group Health Associates
state: Ohio
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA, The Center for Skin Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
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.