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)

This study has been completed.

Sponsor:

Information provided by:

Peplin

ClinicalTrials.gov Identifier:

NCT00917306

First received: June 8, 2009

Last updated: April 30, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 8, 2009
Last Updated Date	April 30, 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: October 6, 2010)	Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 8, 2009)	To evaluate the safety of PEP005 Gel when applied to patients with actinic keratosis [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00917306 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Efficacy (complete and partial clearance of AK lesions) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 8, 2009)	To evaluate the efficacy of PEP005 Gel when applied to patients with actinic keratosis [ 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 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 ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Actinic Keratosis
Intervention ^ICMJE	Drug: PEP005 Gel 0.05% two day treatment
Study Arm (s)	Experimental: 1 Intervention: Drug: PEP005 Gel
Publications *	Not Provided
* 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	102
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 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.
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	NCT00917306
Other Study ID Numbers ^ICMJE	PEP005-020
Has Data Monitoring Committee	No
Responsible Party	Janelle Katsamas, Peplin
Study Sponsor ^ICMJE	Peplin
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Peplin
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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