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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PEP005 (ingenol mebutate) Gel

Group Type EXPERIMENTAL

PEP005 (ingenol mebutate) Gel

Intervention Type DRUG

PEP005 (ingenol mebutate) Gel, 0.01%

Interventions

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PEP005 (ingenol mebutate) Gel

PEP005 (ingenol mebutate) Gel, 0.01%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes