Status:
COMPLETED
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)
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00700063
Start Date
June 1 2008
End Date
October 1 2008
Last Update
April 14 2015
Active Locations (28)
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1
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
2
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
3
Koppel Dermatology
Los Angeles, California, United States, 70072
4
Dermatology Research Associates
Los Angeles, California, United States, 90045