Clinical trial NCT00915551: 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-IIb)
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: 278
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: Complete Clearance of Actinic Keratoses (AK) Lesions
timeFrame: baseline and 57 days
Secondary outcomes:
measure: Partial Clearance of Actinic Keratoses (AK)
timeFrame: baseline and 57 days
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology
state: California
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Carmel
country: United States
facility: Laser Skin Surgery Center of Indiana
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
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: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser Vein Specialists of the Carolinas
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
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: Progressive Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education and Research Foundation
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Carina Heights
country: Australia
facility: South East Dermatology, Belmont Specialist Centre
state: Queensland
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.