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Completed

NCT Number: NCT01214564

Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

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Key information

Conditions

Seborrheic Keratosis Keratosis Keratosis, Actinic Keratosis, Seborrheic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southderm Pty Ltd, Kogarah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is male or female and at least 18 years of age.
  • 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 lesions 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

0.05%

Primary outcomes

  1. To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

    Time frame: Day 43

Secondary outcomes

  1. To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.

    Time frame: Day 43

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Registry information

Official study title

A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
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.

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