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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00916006




Registration number
NCT00916006
Ethics application status
Date submitted
4/06/2009
Date registered
5/06/2009
Date last updated
13/03/2015

Titles & IDs
Public title
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Scientific title
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Secondary ID [1] 0 0
PEP005-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 0 0
Actinic Keratosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEP005 Gel
Treatment: Drugs - Vehicle gel
Treatment: Drugs - PEP005 Gel
Treatment: Drugs - Vehicle gel

Experimental: PEP005 gel - PEP005 gel, 0.015% applied once daily for three consecutive days

Placebo Comparator: Vehicle gel - Vehicle gel applied once daily for three consecutive days

Experimental: PEP005 gel - PEP005 gel, 0.015% applied once daily for three consecutive days

Placebo Comparator: Vehicle gel - Vehicle gel applied once daily for three consecutive days


Treatment: Drugs: PEP005 Gel
0.015%, three day treatment

Treatment: Drugs: Vehicle gel
Vehicle gel, three day treatment

Treatment: Drugs: PEP005 Gel
0.015%, three day treatment

Treatment: Drugs: Vehicle gel
Vehicle gel, three 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 (AK) Lesions. - Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Timepoint [1] 0 0
57 days
Primary outcome [2] 0 0
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. - Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Timepoint [2] 0 0
57 days
Secondary outcome [1] 0 0
Patients With Partial Clearance of Actinic Keratosis (AK) - Patients with partial clearance defined as = 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
Timepoint [1] 0 0
baseline and 57 days
Secondary outcome [2] 0 0
Patients With Partial Clearance of Actinic Keratosis (AK) - Patients with partial clearance defined as = 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
Timepoint [2] 0 0
baseline and 57 days

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

- Female patients must be of either:

- Non-childbearing potential, post-menopausal

- Childbearing potential, provided there are negative serum and urine pregnancy
test results prior to study treatment, to rule out pregnancy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected 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
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
Recruitment hospital [1] 0 0
Southderm Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
St George Dematology and Skin Cancer Centre - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
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
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia

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

Ethics approval
Ethics application status

Summary
Brief summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when
applied to an area of skin containing 4-8 AK lesions on the face or scalp.
Trial website
https://clinicaltrials.gov/show/NCT00916006
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
Other publications