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

This study has been completed.
Sponsor:
Collaborator:
LEO Pharma
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT01302925
First received: February 22, 2011
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Healthy
Actinic Keratosis
Drug: PEP005 Gel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Peplin:

Primary Outcome Measures:
  • Local Skin Responses [ Time Frame: Up to 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Rikke L Fischer/International Clinical Trial Manager, LEO Pharma
ClinicalTrials.gov Identifier: NCT01302925     History of Changes
Other Study ID Numbers: LP0041-01
Study First Received: February 22, 2011
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014