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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00659893




Registration number
NCT00659893
Ethics application status
Date submitted
15/04/2008
Date registered
17/04/2008
Date last updated
14/09/2015

Titles & IDs
Public title
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Scientific title
A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Secondary ID [1] 0 0
PEP005-022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 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 Topical gel

Experimental: 1 - Cohort 1 One 25 cm2 treatment area; on one arm

Experimental: 2 - Cohort 2 One 50cm2 contiguous treatment area; on one arm

Experimental: 3 - Cohort 3 Two 25cm2 treatment areas; one on each arm

Experimental: 4 - Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm

Experimental: 5 - Cohort 5 One 75cm2 contiguous treatment area; on one arm

Experimental: 6 - Cohort 6 Two 50cm2 contiguous treatment area; one on each arm

Experimental: 7 - Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm

Experimental: 8 - Cohort 8 One 100cm2 contiguous treatment area; on one arm


Treatment: Drugs: PEP005 Topical gel
0.05%, two day dose

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

Outcomes
Primary outcome [1] 0 0
Safety and tolerability (incidence of AEs, SAEs and skin responses)
Timepoint [1] 0 0
Screening to End of Study (Day 57)

Eligibility
Key inclusion criteria
- Must be male and at least 18 years of age.

- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal
aspect) forearms, each containing a minimum of 5 AK lesions.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision,
curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):
within 2 weeks and within 2 cm of the selected treatment area(s).

- Treatment with immunomodulators, or interferon/ interferon inducers or systemic
medications that suppress the immune system: within 4 weeks.

- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks
and within 2 cm of the selected treatment area(s).

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
Factorial
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St George Dematology and Skin and Cancer Centre - Kogarah, Sydney
Recruitment hospital [2] 0 0
South East Dermatology, Belmont Specialist Centre - Carina Heights, Brisbane
Recruitment hospital [3] 0 0
Skin and Cancer Foundation - Carlton, Melbourne
Recruitment hospital [4] 0 0
St John of God Dermatology - Subiaco, Perth
Recruitment hospital [5] 0 0
Burswood Dermatology - Victoria Park, Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah, Sydney
Recruitment postcode(s) [2] 0 0
4152 - Carina Heights, Brisbane
Recruitment postcode(s) [3] 0 0
3053 - Carlton, Melbourne
Recruitment postcode(s) [4] 0 0
6008 - Subiaco, Perth
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park, Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas

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

Ethics approval
Ethics application status

Summary
Brief summary
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25
cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
Trial website
https://clinicaltrials.gov/show/NCT00659893
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
George Schmieder, DO
Address 0 0
Park Avenue Dermatology
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
Other publications