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OpenTrials
Completed

NCT Number: NCT00917306

A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic 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 3

Primary location

Dematology on Ward, Adelaide, South Australia, 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 patient must be of either:
  • Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
  • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion criteria

  • Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
  • Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.

Treatment and study plan

PEP005 Gel

Drug

0.05% two day treatment

Other names: PEP005

Primary outcomes

  1. Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)

    Time frame: 57 days

Secondary outcomes

  1. Efficacy (complete and partial clearance of AK lesions)

    Time frame: 57 days

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Collaborators

  • TKL Research, Inc.

Registry information

Official study title

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 10, 2009
Registry last updated
Apr 15, 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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