Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000920998
Ethics application status
Approved
Date submitted
25/08/2011
Date registered
29/08/2011
Date last updated
14/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of Abalone Haemocyanin for cold sores
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Evaluate Safety and Efficacy of Topical Abalone Haemocyanin Once Daily for the Treatment of Herpes Labialis in Immunocompetent Patients
Secondary ID [1] 262915 0
MBA-001-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Labialis (cold sores) 270643 0
Condition category
Condition code
Infection 270817 270817 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Abalone Haemocyanin (AH) 50mg applied topically once daily for 5 days within 6 hours of profromal symptom.
Intervention code [1] 269270 0
Treatment: Drugs
Comparator / control treatment
Placebo solution applied topically
Control group
Placebo

Outcomes
Primary outcome [1] 279511 0
The primary objective is to evaluate the duration of cold sore episodes in subjects treated with AH as compared with placebo.
Timepoint [1] 279511 0
From the date and time of prodromal symptom onset until the date and time the subject self-assessed the lesion was healed.
Secondary outcome [1] 287772 0
To evaluate the efficacy of AH in preventing or blocking cold sore lesion development. This will be assessed by a subject diary recording of progression and duration of cold sore development. Also by Investigator clinical assessment.
Timepoint [1] 287772 0
From the date and time of prodromal symptom onset until the date and time the subject self-assessed the lesion was healed.
Secondary outcome [2] 287773 0
To evaluate the safety and tolerability of topical AH 50mg administered once daily for 5 days. This will be assessed by recording of adverse events, laboratory tests (haematology, biochemistry and urinalysis) and other clinical assessments (physical exam, vital signs and ECG).
Timepoint [2] 287773 0
From the date and time of prodromal symptom onset until the date and time the subject self-assessed the lesion was healed.

Eligibility
Key inclusion criteria
Male or female with history of recurrent cold sores and have experienced at least three episodes in the previous 12 months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant unstable medical condition, allergic reaction or sensitivity to haemocyanin from any source, or a food allergy to seafood or shellfish.

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)
Eligible subjects will be randomised (1:1 ratio) to receive either active abalone haemocyanin or placebo. Allocation will be concealed and done by a central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is via Interactive Web Response System
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
Recruiting
Date of first participant enrolment
Anticipated
25/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4402 0
2010
Recruitment postcode(s) [2] 4403 0
2522

Funding & Sponsors
Funding source category [1] 269735 0
Commercial sector/Industry
Name [1] 269735 0
Marine Biotechnology Australia Pty Limited
Country [1] 269735 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marine Biotechnology Australia Pty Limited
Address
15 Maxwell Road, Hobart, Tasmania, 7000 Australia
Country
Australia
Secondary sponsor category [1] 268778 0
None
Name [1] 268778 0
Address [1] 268778 0
Country [1] 268778 0
Other collaborator category [1] 252228 0
Commercial sector/Industry
Name [1] 252228 0
Novotech (Australia) Pty Limited
Address [1] 252228 0
235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 252228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271700 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 271700 0
229 Greenhill Road, Dulwich SA 5065
Ethics committee country [1] 271700 0
Australia
Date submitted for ethics approval [1] 271700 0
Approval date [1] 271700 0
16/06/2011
Ethics approval number [1] 271700 0
2011-05-262

Summary
Brief summary
Herpes labialis (cold sores) caused by herpes simplex virus type 1 (HSV-1) is a common condition affecting millions of people worldwide. The pathogenesis of the disease suggests that brief and early immunogenic therapy may be a logical approach.
Abalone Haemocyanin (AH) derived from live abalone. The literature and clinical data generated by the sponsor of this study, indicate that AH has the potential for prophylaxis and therapeutic treatment of all stages of oral herpes.
The proposed study is to look at the safety and effectiveness of topical AH for 5 days compared with placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33073 0
Address 33073 0
Country 33073 0
Phone 33073 0
Fax 33073 0
Email 33073 0
Contact person for public queries
Name 16320 0
Adrian Cuthbertson
Address 16320 0
Marine Biotechnology Australia Pty Limited
15 Maxwells Road
Hobart, Tasmania 7000
Australia
Country 16320 0
Australia
Phone 16320 0
+61 (0) 3 6248 5739
Fax 16320 0
+61 (0) 3 6248 5740
Email 16320 0
acuthbertson@bigpond.com
Contact person for scientific queries
Name 7248 0
Alek Safarian
Address 7248 0
Novotech (Australia) Pty Limited
Level 3, 235 Pyrmont St
Pyrmont NSW 2009
Australia
Country 7248 0
Australia
Phone 7248 0
+ 612 8569 1400
Fax 7248 0
+ 612 8569 1498
Email 7248 0
alek.safarian@novotech-cro.com

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
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