A Multi-Center, Open Label, Dose-Area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Actinic Keratosis
Male
Actinic Keratosis
Trial Information
A Multi-Center, Open Label, Dose-Area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability (incidence of AEs, SAEs and skin responses)
Outcome Time Frame:
Screening to End of Study
Safety Issue:
Yes
Principal Investigator
George Schmieder, DO
Investigator Role:
Principal Investigator
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-022
NCT ID:
NCT00659893
Start Date:
April 2008
Completion Date:
November 2008
Related Keywords:
- Actinic Keratosis
- Peplin
- PEP005
- Actinic Keratosis
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Park Avenue Dermatology | Orange Park, Florida 32073 |
| Radiant Research | 7042 East Broadway Tucson, Arizona 85710 |
| Advanced Dermatology and Cosmetic Surgery | 1120 Citrus Tower Blvd, Suite 330 Clermont, Florida 34711 |
| Skin Surgery Medical Group Inc. | 5222 Balboa Avenue Sixth Floor, San Diego, California |
| Radiant Research Inc. | Pinellas Park, Florida 33781 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Karen S. Harkaway, MD LLC | Delran, New Jersey 08075 |
| J&S Studies | College Station, Texas 77845 |
