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

Actinic Keratosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659893
• Other study ID #: PEP005-022
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2008
• Last updated: September 11, 2015
• Start date: April 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 Topical gel
0.05%, two day dose

Locations

Country	Name	City	State
Australia	South East Dermatology, Belmont Specialist Centre	Carina Heights, Brisbane	Queensland
Australia	Skin and Cancer Foundation	Carlton, Melbourne	Victoria
Australia	St George Dematology and Skin and Cancer Centre	Kogarah, Sydney	New South Wales
Australia	St John of God Dermatology	Subiaco, Perth	Western Australia
Australia	Burswood Dermatology	Victoria Park, Perth	Western Australia
United States	J&S Studies	College Station	Texas
United States	Karen S. Harkaway, MD LLC	Delran	New Jersey
United States	Medaphase Inc	Newnan	Georgia
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Advanced Dermatology and Cosmetic Surgery	Ormond Beach	Florida
United States	Radiant Research Inc.	Pinellas Park	Florida
United States	Skin Surgery Medical Group Inc.	San Diego	California
United States	Radiant Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (incidence of AEs, SAEs and skin responses)		Screening to End of Study (Day 57)	Yes

External Links

•   Clinical Trials at LEO Pharma
•   Food and Drug Administration
•   Therapeutic Goods Administration