Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Completed · Phase 1

Conditions studied: Actinic Keratosis

In brief

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

Key facts

Study ID

NCT00659893

Run by

Peplin

People needed

64

Starts

2008-04-01

Expected to finish

2008-11-01

Last updated by the study team

2015-09-14

Who can join

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

You may qualify if…

• Must be male and at least 18 years of age.
• A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.

You may not qualify if…

• Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
• 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 within 2 cm of the selected treatment area(s).

Where it is running

• Radiant Research — Tucson, Arizona, United States
• Skin Surgery Medical Group Inc. — San Diego, California, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Advanced Dermatology and Cosmetic Surgery — Ormond Beach, Florida, United States
• Radiant Research Inc. — Pinellas Park, Florida, United States
• Medaphase Inc — Newnan, Georgia, United States
• Karen S. Harkaway, MD LLC — Riverside Park, New Jersey, United States
• J&S Studies — College Station, Texas, United States
• St George Dematology and Skin and Cancer Centre — Kogarah, Sydney, New South Wales, Australia
• South East Dermatology, Belmont Specialist Centre — Carina Heights, Brisbane, Queensland, Australia
• Skin and Cancer Foundation — Carlton, Melbourne, Victoria, Australia
• St John of God Dermatology — Subiaco, Perth, Western Australia, Australia
• Burswood Dermatology — Victoria Park, Perth, Western Australia, Australia

Full record on ClinicalTrials.gov

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