An Open-Label, Multi-Centre, Dose-Escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.
18 Years
N/A
Both
Actinic Keratoses
Trial Information
An Open-Label, Multi-Centre, Dose-Escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.
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.
Inclusion Criteria
1. Male patients at least 18 years of age.
2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months,
or without a uterus.
3. Four to eight clinically typical, visible and discrete AK lesions within a contiguous
25 cm2 treatment area on the face or face and scalp.
5. Ability to follow study instructions and likely to complete all study requirements.
6. Written informed consent has been obtained. 7. Agreement from the patient to allow
photographs of the selected AK treatment area to be taken and used as part of the study
data package.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
Principal Investigator
Janelle Katsamas
Investigator Role:
Study Director
Investigator Affiliation:
Peplin Operations Pty Ltd
Authority:
Australia: Human Research Ethics Committee
Study ID:
PEP005-007
NCT ID:
NCT00427050
Start Date:
January 2007
Completion Date:
November 2007
Related Keywords:
- Actinic Keratoses
- Actinic Keratoses (AK)
- PEP005
- Topical
- Dermatology
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|
