NCT00850811CompletedPhase 1
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
Peplin1 site in 1 country30 target enrollmentStarted: February 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
1
Experimental
Intervention: PEP005 (ingenol mebutate) Gel (Drug)
Outcomes
Primary Outcomes
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
Time Frame: 4 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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