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)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Peplin

ClinicalTrials.gov Identifier:

NCT00915551

First received: June 4, 2009

Last updated: March 21, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 4, 2009
Last Updated Date	March 21, 2012
Start Date ^ICMJE	June 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 18, 2012)	Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ] Complete clearance of the treatment field
Original Primary Outcome Measures ^ICMJE (submitted: June 5, 2009)	To evaluate the efficacy of PEP005 Gel, 0.015% when applied in patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00915551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 18, 2012)	Partial Clearance of Actinic Keratoses (AK) [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ] Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area
Original Secondary Outcome Measures ^ICMJE (submitted: June 5, 2009)	To evaluate the safety of PEP005 Gel, 0.015% when applied in patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Actinic Keratosis
Intervention ^ICMJE	Drug: PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days Drug: Vehicle Gel once daily for 3 consecutive days
Study Arm (s)	Experimental: PEP005 (Ingenol Mebutate) gel Intervention: Drug: PEP005 (Ingenol Mebutate) gel, 0.015% Placebo Comparator: Vehicle gel 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	278
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
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, Australia

Administrative Information
NCT Number ^ICMJE	NCT00915551
Other Study ID Numbers ^ICMJE	PEP005-025
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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