PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate Gel Followed by Hand Washing in Healthy Subjects

Peplin

Status and phase

Completed

Phase 1

Conditions

Healthy

Actinic Keratosis

Treatments

Drug: PEP005 Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01302925

LP0041-01

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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