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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
History of Changes
  Purpose

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


Condition Intervention Phase
Actinic Keratoses
 Drug: PEP005
 Phase 1

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 8
Study Start Date: October 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
 Drug: PEP005

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544258

Locations
Australia, Queensland
Siller Medical
Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, Australia, 4000
Sponsors and Collaborators
Peplin
Investigators
Study Director: Janelle Katsamas Peplin
  More Information

Additional Information:
Queensland Institute of Medical Research  This link exits the ClinicalTrials.gov site
Q-Pharm Ltd  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00544258     History of Changes
Other Study ID Numbers: PEP005-013
Study First Received: October 14, 2007
Last Updated: May 22, 2008
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
Pharmacokinetic study
Actinic Keratosis
Topical
Dermatology

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on October 17, 2012