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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)
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
Timepoint [1] 0 0
57 days
Primary outcome [2] 0 0
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
Timepoint [3] 0 0
Baseline
Primary outcome [4] 0 0
Incidence Rate and Severity of LSRs Following Study Medication Application
Timepoint [4] 0 0
Day 57
Primary outcome [5] 0 0
Incidence of Hyperpigmentation Following Study Medication Application
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
Incidence of Hyperpigmentation Following Study Medication Application
Timepoint [6] 0 0
Day 57
Primary outcome [7] 0 0
Incidence of Hypopigmentation Following Study Medication Application
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Incidence of Hypopigmentation Following Study Medication Application
Timepoint [8] 0 0
Day 57
Primary outcome [9] 0 0
Incidence of Scarring Following Study Medication Application
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
Incidence of Scarring Following Study Medication Application
Timepoint [10] 0 0
Day 57
Primary outcome [11] 0 0
Complete Clearance Rate of AK Lesions;
Timepoint [11] 0 0
Day 57
Secondary outcome [1] 0 0
Efficacy (Clearance of AK Lesions) Partial Clearance Rate
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
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 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
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
265
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00700063