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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00107965




Registration number
NCT00107965
Ethics application status
Date submitted
11/04/2005
Date registered
12/04/2005
Date last updated
25/03/2015

Titles & IDs
Public title
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
Scientific title
A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses
Secondary ID [1] 0 0
2005/145
Secondary ID [2] 0 0
PEP005-001
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
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005
Treatment: Drugs - PEP005

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Placebo Comparator: 4 -

Experimental: 5 -

Experimental: 6 -

Experimental: 7 -

Placebo Comparator: 8 -


Treatment: Drugs: PEP005
0.0025% PEP005 Topical Gel (Day 1,2 application)

Treatment: Drugs: PEP005
0.01% PEP005 Topical Gel (Day 1,2 application)

Treatment: Drugs: PEP005
0.05% PEP005 Topical Gel (Day 1,2 application)

Treatment: Drugs: PEP005
Vehicle Gel (Day 1,2 application)

Treatment: Drugs: PEP005
0.0025% PEP005 Topical Gel (Day 1,8 application)

Treatment: Drugs: PEP005
0.01% PEP005 Topical Gel (Day 1,8 application)

Treatment: Drugs: PEP005
0.05% PEP005 Topical Gel (Day 1,8 application)

Treatment: Drugs: PEP005
Vehicle Gel (Day 1,8 application)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp
Timepoint [1] 0 0
85 days
Secondary outcome [1] 0 0
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses
Timepoint [1] 0 0
85 days

Eligibility
Key inclusion criteria
- Male or female patients

- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A cosmetic or therapeutic procedure:

- within 10 cm of the selected AK lesions during the 3 months prior to study entry
or

- anywhere during the 4 weeks prior to study entry or anticipated treatment during
the study

- Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

- of lesions located within 10 cm of the selected AK lesions during the 3 months
prior to study entry or

- anywhere during the 4 weeks prior to study entry or anticipated treatment during
the study

- Use of acid-containing products, topical retinoids or light chemical peels within 10
cm of the selected AK lesions during the 3 months prior to study entry, or anticipated
treatment in this same area during the study

- Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers
during the 4 weeks prior to study entry or anticipated treatment during the study

- Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to
study entry or anticipated treatment during the study

- Use of systemic retinoids during the 6 months prior to study entry or anticipated
treatment during the study

- Anticipated excessive or prolonged exposure to ultraviolet light or use of topical
salves, creams or ointments to the selected AK lesions during the study

- Females of childbearing potential

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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Siller Medical - Brisbane
Recruitment hospital [3] 0 0
Skin and Cancer Foundation - Melbourne
Recruitment hospital [4] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [5] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [6] 0 0
Private Dermaology Clinic - Fremantle
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
Recruitment postcode(s) [4] 0 0
3168 - Melbourne
Recruitment postcode(s) [5] 0 0
6160 - Fremantle

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether topical application of PEP005 is safe for
the treatment of actinic keratoses.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00107965
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Greg Siller
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/ct2/show/NCT00107965