A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Phase 1
Completed
- Conditions
- Actinic Keratosis
- Interventions
- Drug: PEP005 (ingenol mebutate) Gel
- Registration Number
- NCT00850811
- Lead Sponsor
- Peplin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PEP005 (ingenol mebutate) Gel -
- Primary Outcome Measures
Name Time Method To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure. 4 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TKL Research, Inc.
🇺🇸Paramus, New Jersey, United States