Back to resultsA Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PEP005 (ingenol mebutate) Gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Peplin, PEP005
Eligibility Criteria
Inclusion Criteria:
- healthy males or females;
- in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
- must 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.
Sites / Locations
- TKL Research, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00850811
Brief Title
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Official Title
A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peplin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Peplin, PEP005
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PEP005 (ingenol mebutate) Gel
Intervention Description
PEP005 (ingenol mebutate) Gel, 0.01%
Primary Outcome Measure Information:
Title
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy males or females;
in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
must 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonothan S Dosik, MD
Organizational Affiliation
TKL Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research, Inc.
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24765228
Citation
Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.
Results Reference
derived
Links:
URL
http://www.fda.gov
Description
Food and Drug Authority
Learn more about this trial
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
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