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OpenTrials
Completed

NCT Number: NCT00850811

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL Research, Inc.

Paramus, New Jersey, 07652, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEP005 (ingenol mebutate) Gel

Drug

PEP005 (ingenol mebutate) Gel, 0.01%

Primary outcomes

  1. To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Registry information

Official study title

A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2009
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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