A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis

This study has been completed.

First Received: February 22, 2009 Last Updated: June 3, 2009 History of Changes

Sponsor:	Peplin
Information provided by:	Peplin
ClinicalTrials.gov Identifier:	NCT00852137

Purpose

This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses

Condition	Intervention	Phase
Actinic Keratosis	Drug: PEP005 (ingenol mebutate) Gel Drug: Vehicle Gel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis

Resource links provided by NLM:

Drug Information available for: 3-Ingenyl angelate

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:

To evaluate the potential for systemic exposure of ingenol mebutate when applied in patients with actinic keratosis. [ Time Frame: 57 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of ingenol mebutate when applied in patients with actinic keratosis. [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
To evaluate the efficacy of ingenol mebutate when applied in patients with actinic keratosis. [ Time Frame: Day 57 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	March 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PEP005 (ingenol mebutate) Gel 0.05%, two days treatment
2: Placebo Comparator	Drug: Vehicle Gel two days treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female;
Multiple AK lesions over a 100 cm2 area of skin located on the dorsal aspect of one forearm.

Exclusion Criteria:

Cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected treatment area(s);
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 within 2 cm of the selected treatment area(s).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852137

Locations

United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759

Sponsors and Collaborators

Peplin

Investigators

Principal Investigator:

Michael Jarratt, MD

DermResearch, Inc

More Information

Additional Information:

Sponsor

Food and Drug Authority This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Peplin ( Janice Drew )
Study ID Numbers:	PEP005-017
Study First Received:	February 22, 2009
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00852137 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peplin:

Peplin
PEP005
Actinic Keratosis

Additional relevant MeSH terms:

Keratosis
Skin Diseases

ClinicalTrials.gov processed this record on February 08, 2010