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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/NCT00544258




Registration number
NCT00544258
Ethics application status
Date submitted
14/10/2007
Date registered
16/10/2007
Date last updated
12/02/2015

Titles & IDs
Public title
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
Scientific 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.
Secondary ID [1] 0 0
PEP005-013
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

Experimental: 1 - Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.


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

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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
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
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Siller Medical - Silverton Place, 101 Wickham Terrace, Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Silverton Place, 101 Wickham Terrace, Brisbane

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 extent of systemic absorption of PEP005 when
applied topically for the treatment of actinic keratoses.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00544258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janelle Katsamas
Address 0 0
Peplin
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/NCT00544258