A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the face or scalp.

Key facts

Study ID

NCT00700063

Run by

Peplin

People needed

265

Starts

2008-06-01

Expected to finish

2008-10-01

Last updated by the study team

2015-04-14

Who can join

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

You may qualify if…

• Must be male or female
• Female patients must be of
• Non-childbearing potential;
• Childbearing potential, provided negative pregnancy test and using effective contraception
• 4 to 8 AK lesions on the face or scalp

You may not qualify if…

• 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

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arizona, United States
• Dermatology Research of Arkansas — Little Rock, Arkansas, United States
• Koppel Dermatology — Los Angeles, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Integrated Research Group Inc — Riverside, California, United States
• Skin Surgery Medical Group Inc — San Diego, California, United States
• 470 Castro St Suite 202-204 — San Francisco, California, United States
• Solano Clinical Research — Vallejo, California, United States
• Dermatology Specialists Inc — Vista, California, United States
• Spencer Derm and Skin Surgery Center — St. Petersburg, Florida, United States
• Northwest Clinical Trial — Boise, Idaho, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Christie Clinic — Champaign, Illinois, United States
• South Bend Clinic — South Bend, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• TKL Research, Inc. — Paramus, New Jersey, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• Philadelphia Institute of Dermatology — Philadelphia, Pennsylvania, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120, — Austin, Texas, United States
• Suzanne Bruce and Associates, The Center for Skin Research — Houston, Texas, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Dermatology Associates of Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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