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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
64
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/study/NCT00659893
Trial related presentations / publications
Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00659893