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PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

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.
ClinicalTrials.gov Identifier: NCT01302925
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : September 14, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.

Condition or disease Intervention/treatment Phase
Healthy Actinic Keratosis Drug: PEP005 Gel Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.
Study Start Date : February 2011
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PEP005 Gel 0.05%/2 days
Subjects will be exposed to investigational product for 2 consecutive days.
Drug: PEP005 Gel
PEP005 Gel 0.05% for 2 consecutive days
Experimental: PEP005 Gel 0.015%/3 days
Subjects will be exposed to investigational product for 3 consecutive days.
Drug: PEP005 Gel
PEP005 Gel 0.015% for 3 consecutive days


Outcome Measures

Primary Outcome Measures :
  1. Local Skin Responses [ Time Frame: Up to 8 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be male or female and at least 18 years of age
  • Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
  • Ability to provide informed consent

Exclusion Criteria:

  • Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks
  • Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days
  • Have any signs of skin irritation or damaged skin at or around the dominant index finger
  • Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers
  • Those who are currently participating in any other clinical trial
  • Those known or suspected of not being able to comply with the requirements of the protocol
  • Females who are pregnant or are breastfeeding
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): NCT01302925


Locations
United States, New Jersey
TKL Research
Paramus, New Jersey, United States
Sponsors and Collaborators
Peplin
LEO Pharma
Investigators
Principal Investigator: Jonathan Dosik, MD TKL Research
More Information

Additional Information:
FDA  This link exits the ClinicalTrials.gov site

Responsible Party: Rikke L Fischer/International Clinical Trial Manager, LEO Pharma
ClinicalTrials.gov Identifier: NCT01302925     History of Changes
Other Study ID Numbers: LP0041-01
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: May 2012

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