PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2011 |
| End Date: | March 2011 |
PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.
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.
following exposure to PEP005 Gel 0.015% or 0.05% and hand washing once daily, for 2 or 3
consecutive days.
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
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