PEP005 Gel

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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PEP005 Gel 0.05%/2 days

Subjects will be exposed to investigational product for 2 consecutive days.

Group Type EXPERIMENTAL

Intervention Type DRUG

PEP005 Gel 0.05% for 2 consecutive days

PEP005 Gel 0.015%/3 days

Subjects will be exposed to investigational product for 3 consecutive days.

Group Type EXPERIMENTAL

PEP005 Gel

Intervention Type DRUG

PEP005 Gel 0.015% for 3 consecutive days

Interventions

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PEP005 Gel

PEP005 Gel 0.05% for 2 consecutive days

Intervention Type DRUG

PEP005 Gel

PEP005 Gel 0.015% for 3 consecutive days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes