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Completed

NCT Number: NCT00915551

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

The Skin Centre, Benowa, Queensland, 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, 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 (Ingenol Mebutate) gel, 0.015%

Drug

once daily for 3 consecutive days

Vehicle gel

Drug

once daily for 3 consecutive days

Primary outcomes

  1. Complete Clearance of Actinic Keratoses (AK) Lesions

    Time frame: baseline and 57 days

    Complete clearance of the treatment field

Secondary outcomes

  1. Partial Clearance of Actinic Keratoses (AK)

    Time frame: baseline and 57 days

    Partial clearance defined as ≥ 75% reduction in the number of 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-IIb)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2009
Registry last updated
Mar 6, 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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