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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00850681
First received: February 23, 2009
Last updated: April 26, 2009
Last verified: April 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:
Food and Drug Authority  This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Peplin:
Peplin
PEP005

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013