A Study to Evaluate the Photoirritation 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

NCT00850811

PEP005-023

Details and patient eligibility

About

This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Treatment:

Drug: PEP005 (ingenol mebutate) Gel