A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

This study has been completed.

First Received: February 23, 2009 Last Updated: April 26, 2009 History of Changes

Sponsored by:	Peplin
Information provided by:	Peplin
ClinicalTrials.gov Identifier:	NCT00850681

Purpose

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design

Resource links provided by NLM:

Drug Information available for: 3-Ingenyl angelate

Further study details as provided by Peplin:

Primary Outcome Measures:

To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PEP005 (ingenol mebutate) Gel	Drug: PEP005 (ingenol mebutate) Gel PEP005 (ingenol mebutate) Gel, 0.01%

Eligibility

Criteria

Inclusion Criteria:

are healthy males or females;
in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
read, understand and provide signed informed consent.

Exclusion Criteria:

are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850681

Locations

United States, New Jersey
TKL Research, Inc.
Paramus, New Jersey, United States, 07652

Sponsors and Collaborators

Peplin

Investigators

Principal Investigator:

Jonothan S Dosik, MD

TKL Research, Inc.

More Information

Additional Information:

Sponsor

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

No publications provided

Responsible Party:	Peplin ( Robert Whitfield )
Study ID Numbers:	PEP005-024
Study First Received:	February 23, 2009
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00850681 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peplin:

Peplin
PEP005

Study placed in the following topic categories:

Keratosis
Skin Diseases
Healthy
Tylosis

Additional relevant MeSH terms:

Keratosis
Skin Diseases

ClinicalTrials.gov processed this record on September 10, 2009