- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850681
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
September 7, 2015 updated by: Peplin
A Randomized, Controlled Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers Using an Open Application Photoallergic Test Design
This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Paramus, New Jersey, United States, 07652
- TKL Research, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- are healthy males or females;
- in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
PEP005 (ingenol mebutate) Gel
|
PEP005 (ingenol mebutate) Gel, 0.01%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the photoallergic (sensitizing) potential of PEP005 Gel and it's vehicle on normal skin.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonothan S Dosik, MD, TKL Research, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
February 23, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (Estimate)
February 25, 2009
Study Record Updates
Last Update Posted (Estimate)
September 9, 2015
Last Update Submitted That Met QC Criteria
September 7, 2015
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP005-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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