- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00357916
Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design
April 4, 2016 updated by: Peplin
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design
To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin
To evaluate skin irritation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a repeat insult patch test study.
On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase.
Following a rest period of approximatley 10-14 days, a single challenge application will be performed.
Local tolerability will be assessed visually using an ordinal scoring system.
If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur
Study Type
Interventional
Enrollment
200
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
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New Jersey
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Paramus, New Jersey, United States, 07652
- TKL Research Inc
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-
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 (to be confirmed by medical history);
- are between 18 and 65 years of age;
- have Fitzpatick skin type I, II, III, or IV
- are willing to wait 6 hours after product application to shower;
- in the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm, or abstinence), have a negative urine pregnancy test at Screening, and submit to a pregnancy test prior to the challenge application;
- are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- have acceptable vital signs (ie oral body temperature, blood pressure (systolic and diastolic), and pulse rate) taken and are willing to have them taken at the end of study (EOS, within 7 days of the initial challenge evaluation);
- complete a medical screening procedure; and
- read, understand and provide signed informed consent.
Exclusion Criteria:
- have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- have Fitzpatrick skin type V or VI;
- have excessive hair on their back;
- current drug or alcohol abuse;
- have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and during the study;
- are not willing to refrain from using topical/systemic analgesics such as aspirin, Aleve, Motrin, Advil, or Nuprin within 72 hours prior to and during the study (occasional use of Tylenol will be permitted);
- based on the investigator's initial examination should not participate in the study (ie, non compliance, inability to understand the study and give adequate informed consent)
- are using systemic/locally-acting medications which might counter or influence the study aim during the study and within 2 weeks prior to the beginning of the study (eg, antihistamines, or topical glucocorticosteroids);
- are using systemic/locally-acting anti-inflammitories which might counter or influence the study aim during the study and within 72 hours prior to the beginning of the study;
- are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- have a known sensitivity or allergy to constituents present in the material being evaluated; and/or
- have participated in any clinical testing of an investigational drug within 28-days or any clinical patch study within 14-days prior to 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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.
|
Secondary Outcome Measures
Outcome Measure |
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To evaluate skin irritation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathon Dosik, MD, TKL Research, Inc.
- Study Director: Peter Welburn, PhD, Peplin Operations (Sponsor)
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
June 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
July 26, 2006
First Submitted That Met QC Criteria
July 26, 2006
First Posted (Estimate)
July 28, 2006
Study Record Updates
Last Update Posted (Estimate)
April 5, 2016
Last Update Submitted That Met QC Criteria
April 4, 2016
Last Verified
April 1, 2016
More Information
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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