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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00427050




Registration number
NCT00427050
Ethics application status
Date submitted
24/01/2007
Date registered
26/01/2007
Date last updated
14/09/2015

Titles & IDs
Public title
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
Scientific 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.
Secondary ID [1] 0 0
PEP005-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratoses 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEP005

Treatment: Drugs: PEP005
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Skin and Cancer Foundation - Darlinghurst
Recruitment hospital [2] 0 0
Southderm Pty Ltd - Kogarah
Recruitment hospital [3] 0 0
St George Dermatology and Skin Cancer Centre - Level 3, 22 Belgrave St, Kogarah
Recruitment hospital [4] 0 0
South East Dermatology - Belmont Specialist Centre, 1202 Creek Rd, Carina Heights
Recruitment hospital [5] 0 0
The Skin Centre - Benowa
Recruitment hospital [6] 0 0
Siller Medical - Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
2217 - Level 3, 22 Belgrave St, Kogarah
Recruitment postcode(s) [4] 0 0
4152 - Belmont Specialist Centre, 1202 Creek Rd, Carina Heights
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Peplin
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00427050
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janelle Katsamas
Address 0 0
Peplin Operations Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00427050