Skip to main content
OpenTrials
Completed

NCT Number: NCT00942604

A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Actinic Keratoses 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

Burke Pharmaceutical Research, Hot Springs, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be male or female and at least 18 years of age.
  • Female patients must be of:
  • Non-childbearing potential;
  • Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
  • 4 to 8 AK lesions on non-head locations.

Exclusion criteria

  • Cosmetic or therapeutic procedures within 2 weeks and within 2 cm 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 treatment area

Treatment and study plan

PEP005 (ingenol mebutate) Gel

Drug

two day treatment

Vehicle gel

Drug

two day treatment

Primary outcomes

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

    Time frame: 57 days

    Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area

Secondary outcomes

  1. Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions

    Time frame: 57 days

    Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (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, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.