Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00700063
Registration number
NCT00700063
Ethics application status
Date submitted
15/06/2008
Date registered
18/06/2008
Date last updated
14/04/2015
Titles & IDs
Public title
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Query!
Scientific title
A Multicenter, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of 0.005%, 0.01% and 0.015% PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
Query!
Secondary ID [1]
0
0
PEP005-015
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - Vehicle gel
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - PEP005 Topical Gel
Treatment: Drugs - Vehicle gel
Experimental: 1 -
Experimental: 2 -
Experimental: 3 -
Placebo Comparator: 4 -
Experimental: 5 -
Experimental: 6 -
Experimental: 7 -
Placebo Comparator: 8 -
Treatment: Drugs: PEP005 Topical Gel
0.005%, two days treatment
Treatment: Drugs: PEP005 Topical Gel
0.01%, two days treatment
Treatment: Drugs: PEP005 Topical Gel
0.015%, two days treatment
Treatment: Drugs: Vehicle gel
two days treatment
Treatment: Drugs: PEP005 Topical Gel
0.005%, three days treatment
Treatment: Drugs: PEP005 Topical Gel
0.01%, three days treatment
Treatment: Drugs: PEP005 Topical Gel
0.015%, three days treatment
Treatment: Drugs: Vehicle gel
three days treatment
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence of AEs Recorded Throughout the Study
Query!
Assessment method [1]
0
0
Incidence of AEs recorded throughout the study
Query!
Timepoint [1]
0
0
57 days
Query!
Primary outcome [2]
0
0
Incidence of SAE Recorded Throughout the Study
Query!
Assessment method [2]
0
0
Incidence of SAE recorded throughout the study
Query!
Timepoint [2]
0
0
57 days
Query!
Primary outcome [3]
0
0
Incidence Rate and Severity of LSRs Following Study Medication Application
Query!
Assessment method [3]
0
0
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized.
Query!
Timepoint [3]
0
0
Baseline
Query!
Primary outcome [4]
0
0
Incidence Rate and Severity of LSRs Following Study Medication Application
Query!
Assessment method [4]
0
0
The treatment area was assessed at baseline, Day 1 (pre-dose), and at each subsequent study visit for the presence and grade (0 to 4) of the following LSRs: erythema; flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration. A composite LSR score (0 to 24), reflecting the sum of each individual LSR grade, was calculated for each patient at each visit.
The actual value and change from baseline in the composite LSR score were also summarized.
Query!
Timepoint [4]
0
0
Day 57
Query!
Primary outcome [5]
0
0
Incidence of Hyperpigmentation Following Study Medication Application
Query!
Assessment method [5]
0
0
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Query!
Timepoint [5]
0
0
Baseline
Query!
Primary outcome [6]
0
0
Incidence of Hyperpigmentation Following Study Medication Application
Query!
Assessment method [6]
0
0
The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Query!
Timepoint [6]
0
0
Day 57
Query!
Primary outcome [7]
0
0
Incidence of Hypopigmentation Following Study Medication Application
Query!
Assessment method [7]
0
0
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Query!
Timepoint [7]
0
0
Baseline
Query!
Primary outcome [8]
0
0
Incidence of Hypopigmentation Following Study Medication Application
Query!
Assessment method [8]
0
0
The selected treatment area was assessed for hypopigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any pigmentation was present, the significance and extent of pigmentation and scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Query!
Timepoint [8]
0
0
Day 57
Query!
Primary outcome [9]
0
0
Incidence of Scarring Following Study Medication Application
Query!
Assessment method [9]
0
0
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent)
Query!
Timepoint [9]
0
0
Baseline
Query!
Primary outcome [10]
0
0
Incidence of Scarring Following Study Medication Application
Query!
Assessment method [10]
0
0
The selected treatment area was assessed for scarring at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted. If any scarring was present, the significance and extent of scarring was recorded. At all timepoints, pigmentation evaluations were performed by a board certified Dermatologist (or equivalent).
Query!
Timepoint [10]
0
0
Day 57
Query!
Primary outcome [11]
0
0
Complete Clearance Rate of AK Lesions;
Query!
Assessment method [11]
0
0
Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Query!
Timepoint [11]
0
0
Day 57
Query!
Secondary outcome [1]
0
0
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
Query!
Assessment method [1]
0
0
Partial clearence rate, defined as the number of patients at the Day 57 visit with a 75% or greater reduction in the number of AK lesions identified at baseline, in the Face and Scalp
Query!
Timepoint [1]
0
0
57 days
Query!
Eligibility
Key inclusion criteria
- Must be male or female
- Female patients must be of
- Non-childbearing potential;
- Childbearing potential, provided negative pregnancy test and using effective
contraception
- 4 to 8 AK lesions on the face or scalp
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
265
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Southderm Pty Ltd - Kogarah
Query!
Recruitment hospital [2]
0
0
The Skin Centre - Benowa
Query!
Recruitment hospital [3]
0
0
Siller Medical - Brisbane
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [3]
0
0
4000 - Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Minnesota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Mexico
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oregon
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Peplin
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This Phase IIb study is designed to assess the safety and efficacy of 0.005%, 0.01% and
0.015% PEP005 Topical Gel when applied to an area of skin, containing 4-8 AK lesions on the
face or scalp.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00700063
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00700063
Download to PDF