Clinical trial NCT00916006: A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Official title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 269
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: This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female and at least 18 years of age
* Female patients must be of either:

  * Non-childbearing potential, post-menopausal
  * Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria:

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

Primary outcomes:
measure: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
timeFrame: 57 days
Secondary outcomes:
measure: Patients With Partial Clearance of Actinic Keratosis (AK)
timeFrame: baseline and 57 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists Inc
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group Inc.
state: California
city: San Francisco
country: United States
facility: Conant Medical Group
state: California
city: Miami
country: United States
facility: University of Miami, Skin Research Camp
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Newnan
country: United States
facility: Medaphase Inc
state: Georgia
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretein Clinical Research Group, LLC
state: Indiana
city: Owensboro
country: United States
facility: Pedia Research LLC
state: Kentucky
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Tyler
country: United States
facility: Dermatology Associates of Tyler
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Kogarah
country: Australia
facility: St George Dematology and Skin Cancer Centre
state: New South Wales
Study officials:
affiliation: Chief Medical Officer
name: Eugene Bauer, MD
role: STUDY_DIRECTOR
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.