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)

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT00915551

Run by

Peplin

People needed

278

Starts

2009-06-01

Expected to finish

2009-09-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arizona, United States
• Center for Dermatology — Fremont, California, United States
• North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Laser Skin Surgery Center of Indiana — Carmel, Indiana, United States
• Deaconess Clinic, Inc — Evansville, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Karl G. Heine Dermatology — Henderson, Nevada, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Dermatology Associates of Rochester, PC — Rochester, New York, United States
• Dermatology, Laser Vein Specialists of the Carolinas — Charlotte, North Carolina, United States
• Oregon Medical Research Center, PC — Portland, Oregon, United States
• DermResearch, Inc. — Austin, Texas, United States
• Suzanne Bruce and Associates, PA, The Center for Skin Research — Houston, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• The Education and Research Foundation — Lynchburg, Virginia, United States
• Premier Clinical Research — Spokane, Washington, United States
• The Skin Centre — Benowa, Queensland, Australia
• South East Dermatology, Belmont Specialist Centre — Carina Heights, Queensland, Australia

Full record on ClinicalTrials.gov

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