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

Phase 3

Completed

• Conditions: Actinic Keratoses
• Interventions: Drug: PEP005 (ingenol mebutate) Gel; Drug: Vehicle gel

• Registration Number: NCT00942604
• Lead Sponsor: Peplin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-19
• Study First Submitted QC: 2009-07-19
• Study First Posted: 2009-07-21
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Disposition First Submitted: 2010-09-22
• Disposition First Submitted QC: 2010-09-22
• Disposition First Posted: 2010-09-27
• Results First Submitted: 2012-02-21
• Results First Submitted QC: 2012-02-21
• Results First Posted: 2012-03-19
• Status Verified: 2013-11
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEP005 (ingenol mebutate) Gel	PEP005 (ingenol mebutate) Gel	PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle gel	Vehicle gel	Vehicle gel once daily for 2 consecutive days

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions	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 Outcome Measures

Name	Time	Method
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions	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

Trial Locations

Locations (17)

Atlanta Dermatology, Vein & Research Center, LLC; 🇺🇸 Alpharetta, Georgia, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arizona, United States

Skin Surgery Medical Group Inc.; 🇺🇸 San Diego, California, United States

Altman Dermatology Associates; 🇺🇸 Arlington Heights, Illinois, United States

Glazer Dermatology; 🇺🇸 Buffalo Grove, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Deaconess Clinic Downtown; 🇺🇸 Evansville, Indiana, United States

Group Health Associates; 🇺🇸 Cincinnati, Ohio, United States

Dermatology Associates of Tyler; 🇺🇸 Tyler, Texas, United States

Dermatology Research Center, Inc.; 🇺🇸 Salt Lake City, Utah, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Dermatology Clinical Research Center of San Antonio; 🇺🇸 San Antonio, Texas, United States

Suzanne Bruce and Associates, PA, The Center for Skin Research; 🇺🇸 Houston, Texas, United States

Virginia Clinical Research, Inc; 🇺🇸 Norfolk, Virginia, United States

The Education and Research Foundation; 🇺🇸 Lynchburg, Virginia, United States

Skin Specialists, PC; 🇺🇸 Omaha, Nebraska, United States

Karl G. Heine Dermatology; 🇺🇸 Henderson, Nevada, United States