Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
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|ClinicalTrials.gov Identifier: NCT00544258|
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : February 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratoses||Drug: PEP005||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544258
|Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, Australia, 4000|
|Study Director:||Janelle Katsamas||Peplin|