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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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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)
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Secondary ID [1]
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PEP005-015
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis
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Condition category
Condition code
Skin
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Other skin conditions
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Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of AEs Recorded Throughout the Study
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Assessment method [1]
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Incidence of AEs recorded throughout the study
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Timepoint [1]
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57 days
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Primary outcome [2]
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Incidence of SAE Recorded Throughout the Study
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Assessment method [2]
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Incidence of SAE recorded throughout the study
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Timepoint [2]
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57 days
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Primary outcome [3]
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Incidence Rate and Severity of LSRs Following Study Medication Application
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline
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Primary outcome [4]
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Incidence Rate and Severity of LSRs Following Study Medication Application
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Assessment method [4]
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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.
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Timepoint [4]
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Day 57
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Primary outcome [5]
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Incidence of Hyperpigmentation Following Study Medication Application
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Assessment method [5]
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The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
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Timepoint [5]
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Baseline
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Primary outcome [6]
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Incidence of Hyperpigmentation Following Study Medication Application
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Assessment method [6]
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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)
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Timepoint [6]
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Day 57
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Primary outcome [7]
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Incidence of Hypopigmentation Following Study Medication Application
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Assessment method [7]
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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)
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Timepoint [7]
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Baseline
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Primary outcome [8]
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Incidence of Hypopigmentation Following Study Medication Application
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Assessment method [8]
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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)
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Timepoint [8]
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Day 57
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Primary outcome [9]
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Incidence of Scarring Following Study Medication Application
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Assessment method [9]
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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)
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Timepoint [9]
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Baseline
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Primary outcome [10]
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Incidence of Scarring Following Study Medication Application
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Assessment method [10]
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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).
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Timepoint [10]
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Day 57
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Primary outcome [11]
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Complete Clearance Rate of AK Lesions;
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Assessment method [11]
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Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
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Timepoint [11]
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Day 57
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Secondary outcome [1]
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Efficacy (Clearance of AK Lesions) Partial Clearance Rate
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Assessment method [1]
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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
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Timepoint [1]
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57 days
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
265
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Southderm Pty Ltd - Kogarah
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Recruitment hospital [2]
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The Skin Centre - Benowa
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Recruitment hospital [3]
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Siller Medical - Brisbane
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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4000 - Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Arkansas
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Country [3]
0
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United States of America
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State/province [3]
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California
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Country [4]
0
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United States of America
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State/province [4]
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Florida
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Country [5]
0
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United States of America
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State/province [5]
0
0
Idaho
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Country [6]
0
0
United States of America
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State/province [6]
0
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Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
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Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
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Minnesota
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Country [9]
0
0
United States of America
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State/province [9]
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New Jersey
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Country [10]
0
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United States of America
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State/province [10]
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New Mexico
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Country [11]
0
0
United States of America
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State/province [11]
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Oregon
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Country [12]
0
0
United States of America
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State/province [12]
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Pennsylvania
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Country [13]
0
0
United States of America
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State/province [13]
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Tennessee
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Country [14]
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United States of America
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State/province [14]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Peplin
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00700063
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT00700063
Download to PDF