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

February 22, 2011
May 3, 2012
February 2011
March 2011   (final data collection date for primary outcome measure)
Local Skin Responses [ Time Frame: Up to 8 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01302925 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Healthy
  • Actinic Keratosis
  • Drug: PEP005 Gel
    PEP005 Gel 0.05% for 2 consecutive days
  • Drug: PEP005 Gel
    PEP005 Gel 0.015% for 3 consecutive days
  • Experimental: PEP005 Gel 0.05%/2 days
    Subjects will be exposed to investigational product for 2 consecutive days.
    Intervention: Drug: PEP005 Gel
  • Experimental: PEP005 Gel 0.015%/3 days
    Subjects will be exposed to investigational product for 3 consecutive days.
    Intervention: Drug: PEP005 Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01302925
LP0041-01
No
Rikke L Fischer/International Clinical Trial Manager, LEO Pharma
Peplin
LEO Pharma
Principal Investigator: Jonathan Dosik, MD TKL Research
Peplin
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP