Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2

Peplin

Status and phase: Completed; Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: PEP005 Topical gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659893

PEP005-022

Details and patient eligibility

About

Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.

Enrollment: 64 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

64 participants in 8 patient groups

1

Experimental group

Description:

Cohort 1 One 25 cm2 treatment area; on one arm

Treatment:

Drug: PEP005 Topical gel

2

Experimental group

Description:

Cohort 2 One 50cm2 contiguous treatment area; on one arm

Treatment:

Drug: PEP005 Topical gel

3

Experimental group

Description:

Cohort 3 Two 25cm2 treatment areas; one on each arm

Treatment:

Drug: PEP005 Topical gel

4

Experimental group

Description:

Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm

Treatment:

Drug: PEP005 Topical gel

5

Experimental group

Description:

Cohort 5 One 75cm2 contiguous treatment area; on one arm

Treatment:

Drug: PEP005 Topical gel

6

Experimental group

Description:

Cohort 6 Two 50cm2 contiguous treatment area; one on each arm

Treatment:

Drug: PEP005 Topical gel

7

Experimental group

Description:

Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm

Treatment:

Drug: PEP005 Topical gel

8

Experimental group

Description:

Cohort 8 One 100cm2 contiguous treatment area; on one arm

Treatment:

Drug: PEP005 Topical gel