Status:
COMPLETED
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)
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00915551
Start Date
June 1 2009
End Date
September 1 2009
Last Update
March 6 2015
Active Locations (21)
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1
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
2
Center for Dermatology
Fremont, California, United States, 94538
3
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
4
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005