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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/NCT00917306




Registration number
NCT00917306
Ethics application status
Date submitted
8/06/2009
Date registered
10/06/2009
Date last updated
15/04/2015

Titles & IDs
Public title
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Scientific title
A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Secondary ID [1] 0 0
PEP005-020
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 Gel

Experimental: PEP005 gel - PEP005 gel, 0.05% administered once daily for 2 consecutive days


Treatment: Drugs: PEP005 Gel
0.05% two day treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Timepoint [1] 0 0
57 days
Secondary outcome [1] 0 0
Efficacy (complete and partial clearance of AK lesions)
Timepoint [1] 0 0
57 days

Eligibility
Key inclusion criteria
- Patient is male or female and at least 18 years of age.

- Female patient must be of either:

- Non-childbearing potential, post-menopausal, or there is a confirmed clinical
history of sterility (e.g., the patient is without a uterus)

- Childbearing potential, provided there are negative urine pregnancy test results
prior to study treatment, to rule out pregnancy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected
treatment area.

- Treatment with immunomodulators, 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 2 cm of the selected treatment area.

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 3
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
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Dematology on Ward - Adelaide
Recruitment hospital [2] 0 0
Dermatology Institute of Victoria - Melbourne
Recruitment hospital [3] 0 0
St John of God Dermatology - Subiaco
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment postcode(s) [2] 0 0
3141 - Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Peplin
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
TKL Research, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when
applied to an area of skin containing 4-8 AK lesions on non-head locations.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00917306
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Bauer, MD
Address 0 0
Chief Medical Officer
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/NCT00917306