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

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ClinicalTrials.gov Identifier: NCT00850681
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : September 9, 2015
Sponsor:
Information provided by:
Peplin

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

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 (ingenol mebutate) Gel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
PEP005 (ingenol mebutate) Gel
Drug: PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel, 0.01%



Primary Outcome Measures :
  1. To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin. [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Whitfield, Peplin
ClinicalTrials.gov Identifier: NCT00850681     History of Changes
Other Study ID Numbers: PEP005-024
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: April 2009

Keywords provided by Peplin:
Peplin
PEP005

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