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Completed

NCT Number: NCT00916006

A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

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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

Southderm Pty Ltd, Kogarah, New South Wales, 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

  • Patient is male or female and at least 18 years of age
  • Female patients must be of either:
  • Non-childbearing potential, post-menopausal
  • Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion criteria

  • Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area
  • Treatment with immunomodulators, or 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

0.015%, three day treatment

Other names: PEP005

Vehicle gel

Drug

Vehicle gel, three day treatment

Other names: Placebo

Primary outcomes

  1. Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.

    Time frame: 57 days

    Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.

Secondary outcomes

  1. Patients With Partial Clearance of Actinic Keratosis (AK)

    Time frame: baseline and 57 days

    Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area

Sponsors and collaborators

Lead sponsor

Peplin

Industry

Registry information

Official study title

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2009
Registry last updated
Apr 2, 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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