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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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)
Secondary ID [1] 0 0
PEP005-015
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 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of AEs Recorded Throughout the Study - Incidence of AEs recorded throughout the study
Timepoint [1] 0 0
57 days
Primary outcome [2] 0 0
Incidence of SAE Recorded Throughout the Study - Incidence of SAE recorded throughout the study
Timepoint [2] 0 0
57 days
Primary outcome [3] 0 0
Incidence Rate and Severity of LSRs Following Study Medication Application - 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.
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Incidence Rate and Severity of LSRs Following Study Medication Application - 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.
Timepoint [4] 0 0
Day 57
Primary outcome [5] 0 0
Incidence of Hyperpigmentation Following Study Medication Application - The selected treatment area was assessed for hyperpigmentation at baseline (Day 1 pre-dose), Day 57, and at each poststudy followup visit as warranted.
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Incidence of Hyperpigmentation Following Study Medication Application - 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)
Timepoint [6] 0 0
Day 57
Primary outcome [7] 0 0
Incidence of Hypopigmentation Following Study Medication Application - 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)
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Incidence of Hypopigmentation Following Study Medication Application - 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)
Timepoint [8] 0 0
Day 57
Primary outcome [9] 0 0
Incidence of Scarring Following Study Medication Application - 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)
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
Incidence of Scarring Following Study Medication Application - 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).
Timepoint [10] 0 0
Day 57
Primary outcome [11] 0 0
Complete Clearance Rate of AK Lesions; - Defined as the number of patients at the day 57 post-treatment visit with no clinically visible AK lesions in the selected treatment area
Timepoint [11] 0 0
Day 57
Secondary outcome [1] 0 0
Efficacy (Clearance of AK Lesions) Partial Clearance Rate - 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
Timepoint [1] 0 0
57 days

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
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 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 2
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,QLD
Recruitment hospital [1] 0 0
Southderm Pty Ltd - Kogarah
Recruitment hospital [2] 0 0
The Skin Centre - Benowa
Recruitment hospital [3] 0 0
Siller Medical - Brisbane
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4000 - Brisbane
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
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
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
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
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00700063
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

Summary results
Other publications