Actinic Keratosis, Healthy
Conditions
Brief summary
The purpose of this phase 1 trial is to investigate the local tolerability on the finger following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3 consecutive days.
Interventions
DRUGPEP005 Gel
PEP005 Gel 0.05% for 2 consecutive days
Sponsors
LEO Pharma
Peplin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be male or female and at least 18 years of age * Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception * Ability to provide informed consent
Exclusion criteria
* Have received treatment with immunomodulators, or interferon/interferon inducers or systematic medications that suppress the immune system in the last 4 weeks * Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel, cream, lotion) medication within the last 7 days * Have any signs of skin irritation or damaged skin at or around the dominant index finger * Have worked in an occupation with a high risk of being in contact with irritative material (eg. chemicals, painting) on their hands, especially fingers * Those who are currently participating in any other clinical trial * Those known or suspected of not being able to comply with the requirements of the protocol * Females who are pregnant or are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Skin Responses | Up to 8 days |
Countries
United States
Outcome results
None listed