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Trial registered on ANZCTR


Registration number
ACTRN12607000580471
Ethics application status
Not yet submitted
Date submitted
7/11/2007
Date registered
9/11/2007
Date last updated
9/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2, Randomized, Double-Blinded, Vehicle-Controlled, Multicenter Study of Topical AS101 for External Genital Warts
Scientific title
A study of AS101 versus placebo in subjects with external genital warts to evaluate effectiveness and safety.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
External Genital Warts 2488 0
Condition category
Condition code
Infection 2588 2588 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be assigned to one of four treatment groups:
1. AS101 15% ointment twice a day.
2. AS101 15% once a day and placebo ointment once a day.
3. AS101 5% ointment twice a day.
4. Placebo ointment twice a day.
Ointment to be applied for up to 16 weeks, or until complete clearance of external genital warts in the treatment area.
Intervention code [1] 2218 0
Treatment: Drugs
Comparator / control treatment
Placebo ointment twice a day.
Control group
Placebo

Outcomes
Primary outcome [1] 3498 0
To evaluate the efficacy of topical AS101 for the treatment of external genital warts as measured by complete clearance.
Timepoint [1] 3498 0
Weekly for up to a period of 16 weeks.
Secondary outcome [1] 5836 0
To further evaluate efficacy in complete responders by measuring time to complete clearance, recurrence rate, and
time to recurrence
Timepoint [1] 5836 0
Weekly for up to 16 weeks during the treatment period and every 4 weeks during the 12 week follow-up period.
Secondary outcome [2] 5921 0
To assess safety and tolerability of topical AS101
Timepoint [2] 5921 0
Weekly for up to 16 weeks during the treatment period and every 4 weeks during the 12 week follow-up period.
Secondary outcome [3] 5922 0
To compare efficacy and safety among the AS101 treatment groups that demonstrate statistically significantly higher complete clearance rates than that of the vehicle group.
Timepoint [3] 5922 0
Weekly for up to 16 weeks during the treatment period and every 4 weeks during the 12 week follow-up period.

Eligibility
Key inclusion criteria
Men and women 18 years of age or older and in good health;

Clinical diagnosis of external genital warts, in the external genitalia including penis, scrotum, vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas;

A minimum of two (2) warts and a maximum of 50 warts in the Treatment Area;

A maximum Treatment Area (product of maximum perpendicular dimensions) of < 1000 mm2;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Topical or systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days of Day 1, and while on study;

Any treatment for genital warts within 14 days of Day 1, and patients must have completely recovered from skin irritation and other clinical signs or symptoms associated with the prior therapy;

Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days of Day 1 (patients on long-term suppressive antiviral therapy are eligible);

Known history of human immunodeficiency virus (HIV) infection;

Known current acute or chronic infection with hepatitis B or C virus (HBV or HCV);

Cutaneous surgery, including cryosurgery, to genital area within 30 days of Day 1;

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)
After patients meet eligibility criteria, they will be centrally randomized by computer (1:1:1:1) to one of three treatment groups or to a placebo control group. Patients will be assigned a randomization number. The patient and study personnel will be blinded as to which treatment the patient is receiving. Thirty-five patients will be randomized to each study group for a total of 140 patients. Randomization will be stratified by gender.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
140 sequential patients numbered 001 to 140 will be randomised. The randomization will be stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 631 0
New Zealand
State/province [1] 631 0

Funding & Sponsors
Funding source category [1] 2742 0
Commercial sector/Industry
Name [1] 2742 0
Miramar Therapeutics, Inc, USA
Country [1] 2742 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Miramar Therapeutics, Inc, USA
Address
4365 Executive Drive, Suite 1500
San Diego, CA 92121
Country
United States of America
Secondary sponsor category [1] 2477 0
Commercial sector/Industry
Name [1] 2477 0
Novotech (Australia) Pty Ltd
Address [1] 2477 0
Novotech (Australia) Pty Ltd
Level 3, 19 Harris St
Pyrmont, NSW 2009
Country [1] 2477 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4659 0
Ethics committee address [1] 4659 0
Ethics committee country [1] 4659 0
Date submitted for ethics approval [1] 4659 0
17/10/2007
Approval date [1] 4659 0
Ethics approval number [1] 4659 0

Summary
Brief summary
This study will evaluate the safety (i.e. incidence and type of adverse events) and efficacy (i.e. as measured by complete clearance) of AS101 administered twice daily topically over a treatment period of up to 16 weeks, or until complete clearance of external genital warts in the treatment area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28136 0
Address 28136 0
Country 28136 0
Phone 28136 0
Fax 28136 0
Email 28136 0
Contact person for public queries
Name 11293 0
Daniel Gregory
Address 11293 0
Novotech (Australia) Pty Ltd
Level 3, 19 Harris St
Pyrmont, NSW 2009
Country 11293 0
Australia
Phone 11293 0
+61 2 9518 9600
Fax 11293 0
+61 2 9518 9390
Email 11293 0
[email protected]
Contact person for scientific queries
Name 2221 0
Bryan Leigh
Address 2221 0
4365 Executive Drive, Suite 1500
San Diego, CA 92121
Country 2221 0
United States of America
Phone 2221 0
+1 858-731-8500
Fax 2221 0
+1 858-731-8501
Email 2221 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.