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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:
ClinicalTrials.gov Identifier:
NCT00850681
First Posted: February 25, 2009
Last Update Posted: September 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Peplin
  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: 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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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.
  More Information

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 Submitted: February 23, 2009
First Posted: February 25, 2009
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