Clinical trial NCT00917306: A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Official title: A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Peplin
Actinic keratosis
PEP005
Lead sponsor: Peplin
Sponsor class: INDUSTRY
Collaborators: name: TKL Research, Inc.
First posted: 2009-06-10
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.


Eligibility criteria: Inclusion Criteria:

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

  * Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
  * Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria

* Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
* Treatment with immunomodulators, 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: Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
timeFrame: 57 days
Secondary outcomes:
measure: Efficacy (complete and partial clearance of AK lesions)
timeFrame: 57 days
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Park Avenue Dermatology
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: Clinton Twp
country: United States
facility: Michigan Center for Research Corp
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Dermatology Research Associates
state: Tennessee
city: Adelaide
country: Australia
facility: Dematology on Ward
state: South Australia
city: Melbourne
country: Australia
facility: Dermatology Institute of Victoria
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Dermatology
state: Western Australia
Study officials:
affiliation: Chief Medical Officer
name: Eugene Bauer, MD
role: STUDY_DIRECTOR
References: