Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

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 not provided in https://clinicaltrials.gov/study/NCT00107965