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 - Full Text View

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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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:

Cmax for ingenol mebutate, PEP015 and PEP025 levels [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Tmax for ingenol mebutate, PEP015 and PEP025 levels [ Time Frame: 57 days ] [ Designated as safety issue: No ]
AUC(0-24) for ingenol mebutate, PEP015 and PEP025 levels [ Time Frame: 57 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence rate of AEs, serious adverse events (SAEs) and AEs leading to discontinuation of study medication throughout the study [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]
Complete clearance rate; and % reduction in AK lesions, in a 25 cm2 area within the selected treatment area [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
Incidence rate and grade of LSRs, pigmentation and scarring following study medication application [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]

Enrollment:	16
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
Experimental: 1	Drug: PEP005 (ingenol mebutate) Gel 0.05%, two days treatment
Placebo Comparator: 2	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:	Janice Drew, Peplin
ClinicalTrials.gov Identifier:	NCT00852137 History of Changes
Other Study ID Numbers:	PEP005-017
Study First Received:	February 22, 2009
Last Updated:	July 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peplin:

Peplin
PEP005
Actinic Keratosis

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012