Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2008 |
| End Date: | November 2008 |
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)
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25
cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
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).
We found this trial at
9
sites
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