Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.|
- To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
- To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
|Study Start Date:||October 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544258
|Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, Australia, 4000|
|Study Director:||Janelle Katsamas||Peplin|