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/ct2/show/NCT00546611




Registration number
NCT00546611
Ethics application status
Date submitted
18/10/2007
Date registered
19/10/2007
Date last updated
28/01/2016

Titles & IDs
Public title
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)
Scientific title
A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand
Secondary ID [1] 0 0
PEP005-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Warts 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEP005

Active Comparator: 1 - Three day application of 0.05% PEP005 Topical Gel to one or two common warts located on the hand.


Treatment: Drugs: PEP005
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Resolution of Common Wart(s)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Male and female patients at least 18 years of age.

- A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the
dorsal hand.

- Written informed consent has been obtained.

- Agreement from the patient to allow photographs of the common wart(s) treatment area
to be taken and used as part of the study package.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
South East Dermatology, 1202 Creek Rd - Carina Heights, Brisbane
Recruitment postcode(s) [1] 0 0
4152 - Carina Heights, Brisbane

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

Ethics approval
Ethics application status

Summary
Brief summary
Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus
(HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere
(e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like
surface, are typically slightly raised above the surrounding skin and are generally diagnosed
by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No
single therapy has been proven effective at achieving complete remission in every
patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05%
PEP005 Topical Gel.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00546611
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angela Smith
Address 0 0
Peplin Operations Pty Ltd
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/NCT00546611