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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Peplin

ClinicalTrials.gov Identifier:

NCT00942604

First received: July 19, 2009

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 19, 2009
Last Updated Date	March 21, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2012)	Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ] [ Designated as safety issue: No ] Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Original Primary Outcome Measures ^ICMJE (submitted: July 19, 2009)	Efficacy (complete clearance of AKs) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00942604 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 21, 2012)	Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ] [ Designated as safety issue: No ] Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
Original Secondary Outcome Measures ^ICMJE (submitted: July 19, 2009)	Efficacy (partial clearance of AKs) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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)
Brief Summary	The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Actinic Keratoses
Intervention ^ICMJE	Drug: PEP005 (ingenol mebutate) Gel two day treatment Drug: Vehicle gel two day treatment
Study Arm (s)	Active Comparator: PEP005 (ingenol mebutate) Gel PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days Intervention: Drug: PEP005 (ingenol mebutate) Gel Placebo Comparator: Vehicle gel Vehicle gel once daily for 2 consecutive days Intervention: Drug: Vehicle gel
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	203
Completion Date	October 2009
Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00942604
Other Study ID Numbers ^ICMJE	PEP005-028
Has Data Monitoring Committee	No
Responsible Party	Peplin
Study Sponsor ^ICMJE	Peplin
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Peplin
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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