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
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, see Learn About Clinical Studies.

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 October 19, 2014