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Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00544258
First received: October 14, 2007
Last updated: May 22, 2008
Last verified: May 2008

October 14, 2007
May 22, 2008
October 2007
May 2008   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00544258 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
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.

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Actinic Keratoses
Drug: PEP005
Experimental: 1
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
Intervention: Drug: PEP005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male patients at least 18 years of age.
  2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
  3. Written informed consent has been obtained.
  4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00544258
PEP005-013
No
Not Provided
Peplin
Not Provided
Study Director: Janelle Katsamas Peplin
Peplin
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP