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Completed

NCT Number: NCT01214577

Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin

This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.

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Key information

Conditions

Photo-damage

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Skin Centre, Benowa, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients aged 30 to 65 years.
  • Female patients must be of either:
  • Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
  • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
  • Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
  • Patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package.

Exclusion criteria

  • Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel.
  • Current enrolment or participation in a clinical research study within 30 days of entry into this study.

Treatment and study plan

PEP005 (ingenol mebutate) Gel

Drug

0.015%

Primary outcomes

  1. To evaluate the safety of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.

    Time frame: Day 43

Secondary outcomes

  1. To determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.

    Time frame: Day 43

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Registry information

Official study title

A Phase 2a, Multi-Centre, Single Arm Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin on the Face

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Jan 25, 2011

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.