Clinical trial NCT00427050: A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratoses
Keywords: Actinic Keratoses (AK)
PEP005
Topical
Dermatology
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2007-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

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 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.

Primary outcomes:
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
Secondary outcomes:
measure: Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Skin and Cancer Foundation
state: New South Wales
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Level 3, 22 Belgrave St, Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Belmont Specialist Centre, 1202 Creek Rd, Carina Heights
country: Australia
facility: South East Dermatology
state: Queensland
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Brisbane
country: Australia
facility: Siller Medical
state: Queensland
city: Epsom
country: New Zealand
facility: Auckland Dermatology
state: Auckland
city: Hamilton
country: New Zealand
facility: Tristram Clinic
city: Tauranga
country: New Zealand
facility: Skin Centre
Study officials:
affiliation: Peplin Operations Pty Ltd
name: Janelle Katsamas
role: STUDY_DIRECTOR
References: