A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis
Both
Actinic Keratosis
Trial Information
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Incidence of AEs Recorded Throughout the Study
Outcome Description:
Incidence of AEs recorded throughout the study
Outcome Time Frame:
57 days
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-015
NCT ID:
NCT00700063
Start Date:
June 2008
Completion Date:
October 2008
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| South Bend Clinic | South Bend, Indiana 46617 |
| Solano Clinical Research | Vallejo, California 94589 |
| Dermatology Specialists Inc | Vista, California 92083 |
| Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
| Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
| Christie Clinic | Champaign, Illinois 61820 |
| Dermatology Clinical Research Center of San Antonio | San Antonio, Texas 78229 |
| Oregon Medical Research Center | Portland, Oregon 97223 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Philadelphia Institute of Dermatology | Fort Washington, Pennsylvania 19034 |
| Skin Surgery Medical Group Inc | 5222 Balboa Avenue Sixth Floor San Diego, California 92117 |
| Progressive Clinical Research | San Antonio, Texas 78229 |
| Burke Pharmaceutical Research | Hot Springs, Arizona 71913 |
| Dermatology Research of Arkansas | Little Rock, Arkansas 72205 |
| Koppel Dermatology | Los Angeles, California 70072 |
| Integrated Research Group Inc | Riverside, California 92506 |
| 470 Castro St Suite 202-204 | San Francisco, California 94114 |
| Spencer Derm and Skin Surgery Center | St Petersburg, Florida 33716 |
| Northwest Clinical Trial | Boise, Idaho 83704 |
| TKL Research, Inc. | Paramus, New Jersey 07652 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| DermResearch, Inc. 8140 N. MoPac, Bldg. 3, Suite 120, | Austin, Texas 78759 |
| Suzanne Bruce and Associates, The Center for Skin Research | Houston, Texas 77056 |
