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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00742391




Registration number
NCT00742391
Ethics application status
Date submitted
25/08/2008
Date registered
27/08/2008
Date last updated
6/03/2015

Titles & IDs
Public title
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Scientific title
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Secondary ID [1] 0 0
PEP005-014
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 (ingenol mebutate) Gel
Treatment: Drugs - Vehicle gel

Active comparator: 1 - PEP005 (ingenol mebutate) Gel

Placebo comparator: 2 - Vehicle gel


Treatment: Drugs: PEP005 (ingenol mebutate) Gel
two day treatment

Treatment: Drugs: Vehicle gel
two day treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients With Complete Clearance of Actinic Keratosis (AKs)
Timepoint [1] 0 0
57 days
Secondary outcome [1] 0 0
Patients With Partial Clearance of Actinic Keratosis (AKs)
Timepoint [1] 0 0
baseline and 57 days

Eligibility
Key inclusion criteria
* Must be male or female and at least 18 years of age.
* Female patients must be of:
* Non-childbearing potential;
* Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
* 4 to 8 AK lesions on non-head locations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
* 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 2 cm of treatment area

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
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
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
255
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
The Skin Centre - Benowa
Recruitment hospital [2] 0 0
Burswood Dermatology - Victoria Park
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
6100 - Victoria Park
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
Colorado
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
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00742391