A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

Peplin

Status and phase

Completed

Phase 1

Conditions

Actinic Keratosis

Treatments

Drug: PEP005 (ingenol mebutate) Gel

Study type

Interventional

Funder types

Industry

Identifiers

PEP005-024

Details and patient eligibility

About

This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

are healthy males or females;
in the case of females of childbearing potential, are using an acceptable form of birth control and provide a negative urine pregnancy test;
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.