Actinic Keratosis
Conditions
Keywords
Peplin, PEP005
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.
Interventions
PEP005 (ingenol mebutate) Gel, 0.01%
Sponsors
Peplin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure. | 4 days |
Countries
United States
Outcome results
None listed