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Trial registered on ANZCTR
Registration number
ACTRN12618000890235
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
28/05/2018
Date last updated
21/07/2022
Date data sharing statement initially provided
10/05/2019
Date results information initially provided
21/07/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
A topical cold sore treatment containing St John's Wort, Calendula and Copper
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Scientific title
A randomised, double blind, placebo controlled trial of a topical treatment containing Hypericum perforatum, Calendula officinalis and copper sulfate on herpes simplex labialis (HSL).
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Secondary ID [1]
294726
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None
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Universal Trial Number (UTN)
U1111-1233-2426
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Trial acronym
SC001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Herpes Simplex Labialis
307607
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Condition category
Condition code
Skin
306662
306662
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0
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Dermatological conditions
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Alternative and Complementary Medicine
307007
307007
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0
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Herbal remedies
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Infection
307008
307008
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
One topical application (0.5-0.7ml) of the intervention will be applied to the lesion. The application will be performed by the participant, either at home or at the pharmacy. The application will always be guided by a study investigator either by phone or in person.
This single application of the topical treatment containing Hypericum perforatum (St John's Wort), Calendula officinalis (Calendula) and copper sulfate will be applied within 48 hours of the first prodromal symptoms or first clinical signs of herpes simplex labialis. There is only one single dose of the topical treatment applied with no further applications of the treatment during the 14 days or until the skin returns to normal.
Participants will record in a daily online diary, cold sore progression, levels of pain and symptoms and any adverse events during the treatment period.
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Intervention code [1]
301018
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Treatment: Other
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Comparator / control treatment
Placebo control: one topical application of colour, smell and taste matched placebo within 48 hours of the first prodromal symptoms or at the first clinical signs of herpes simplex labialis.
The placebo is identical to the intervention with the exception of the active ingredients: Hypericum perforatum (St John's wort), Calendula officinalis (Calendula) and copper sulfate.
The placebo contains: Blue dye (colour matched to the treatment); Aloe Vera, Glycerol, Vitamin E, Hydroxyethycellulose, polysorbate, purified water.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The effect of the topical treatment on the duration of the herpes simplex labialis wound healing, assessed by the median duration in each group of onset to drying up and healing in days (self-reported).
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Assessment method [1]
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Timepoint [1]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Primary outcome [2]
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The efficacy of one single topical application (0.5-0.7ml) of the treatment in the reduction of episode duration of herpes simplex labialis (HSL), measured in days from the onset of HSL symptoms to healed skin.
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Assessment method [2]
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Timepoint [2]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [1]
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The effect of the topical treatment on the progression of the HSL to ulcerative vs non-ulcerative lesions, assessed by the percentage of lesions in each group that progress to an ulcerative stage. This will be self-reported using a supplied chart with photographs of the stages of wound healing.
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Assessment method [1]
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Timepoint [1]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [2]
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The effect of the topical treatment on pain during the disease course of the herpes simplex labialis, assessed for each group, on a ten point ordinal scale of 0 - 10; (where 0 = no pain and 10 = severe pain) (self-reported).
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Assessment method [2]
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Timepoint [2]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [3]
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Participant level of satisfaction of the topical treatment. The survey is designed specifically for this study.
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Assessment method [3]
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Timepoint [3]
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Participants will receive a survey 2 days after their final pharmacy (clinical) visit.
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Secondary outcome [4]
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The degree of safety of the topical treatment.
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Assessment method [4]
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Timepoint [4]
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Participants will receive an exit survey 2 days after the final pharmacy (clinical) visit. The survey is designed specifically for this study.
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Secondary outcome [5]
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The effect of the topical treatment on burning sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 - 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self-reported).
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Assessment method [5]
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Timepoint [5]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [6]
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The effect of the topical treatment on itching sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 - 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self-reported).
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Assessment method [6]
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Timepoint [6]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [7]
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The effect of the topical treatment on tingling sensation during the disease course of the herpes simplex labialis, assessed for each group, on a four point ordinal scale of 0 - 4; (where 0=not present; 1=mild; 2=moderate; 3=severe) (self-reported).
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Assessment method [7]
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Timepoint [7]
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Secondary outcome [8]
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The degree of acceptability of the topical treatment.
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Assessment method [8]
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Timepoint [8]
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Participants will receive an exit survey 2 days after the final pharmacy (clinical) visit. The survey is designed specifically for this study.
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Secondary outcome [9]
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The effect of the topical treatment on the duration of the herpes simplex labialis wound healing, assessed by the median duration in each group of onset to redness in days (self-reported).
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Assessment method [9]
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Timepoint [9]
347226
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Recorded by participant every day for up to 14 days after the application of the topical treatment.
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Eligibility
Key inclusion criteria
- Females and males from the general population. (Pre-allocation criteria)
- Aged 18-65 years. (Pre-allocation criteria)
- Previous clinical history of HSL, with at least 3 prior episodes. (Pre-allocation criteria)
- Onset of prodromal or clinical symptoms of HSL within the past 48 hours.
- Primary lesion is within 1cm of the lip.
- Willing to provide informed consent and adhere to the protocol. (Pre-allocation criteria)
- Has internet access (either via a mobile or computer) for completing online forms. (Pre-allocation criteria)
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of immunodeficiency, immunosuppression or autoimmune disorder (including HIV, rheumatoid arthritis, psoriasis, and systemic lupus erythematosus, inherited immune deficiency, immune suppression for organ transplantation, immune suppression medication for other inflammatory disorders). (Pre-allocation criteria)
- Individuals with an acute infection not related to the study condition (current viral infections such as cold and flu).
- Use of other antiviral agents (including herbal medications), anti-inflammatory medications or steroids during or within two weeks prior to the treatment period.
- Sensitivity to any of the ingredients in the study treatment. (Pre-allocation criteria)
- Use of any topical agents (including cosmetics, lip balms, sunscreens, etc.) or cosmetic procedures (such as chemical peels or microdermabrasion) on the prodromal or lesion area during the treatment period.
- Mechanical disruption (i.e., scrubbing, lancing, shaving, etc.) of the prodromal area or lesion prohibited during the treatment period.
- Female participants who are lactating, pregnant or planning to become pregnant during the next 14 days. (Pre-allocation criteria)
- Individuals who have participated in another clinical trial within the last 30 days.
- PCR confirmed or probable diagnosis of COVID19 within the last 28 days (Pharmacy recruitment only)
- Known contact with PCR confirmed or probable diagnosis of COVID19 within the last 28 days. (Pharmacy recruitment only)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After signing the informed consent document and satisfying ALL of the eligibility criteria participants will be randomised in a 2:1 ratio to either the active treatment group or the placebo control. A 2:1 ratio was chosen to improve recruitment rates as potential participants are actively seeking treatment when attending the pharmacy, therefore a greater chance of being allocated active treatment will increase recruitment and retention rates. Blocked randomisation, with a block size of 6 will be undertaken. Individual study sites will be able to randomise via a web portal or via text message. Randomisation will provide the study site with a box ID number, the corresponding box will then be dispensed to the participant. There will be no disclosure of group allocation to any site staff or participants.
Once randomised, participants will be given/sent one vial of the active topical treatment, or a colour, viscosity, taste and smell matched placebo in matching plain packaging. The participant, will then apply the intervention once, with guidance from a study investigator, then return the vial and packaging for disposal.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation, with a block size of 6 will be undertaken. Individual study sites will be able to randomise via a web portal or via text message.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Efficacy analyses will be performed for both the intent-to-treat (ITT) population and per-protocol (PP) population. The ITT population will consist of all participants. The PP population will exclude all participants in the ITT population who have missing information.
Continuous data will be summarized using descriptive statistics including the number of observations used in the calculation (n), mean, standard deviation (SD), minimum, median and maximum.
The primary analysis for the primary outcome will be median duration of episode, from the stage at presentation to the clinical site until healing, compared between groups using a two tailed t-test. Secondary outcomes will include Cox proportional hazards for time to healing and time of wound duration, Kaplan-Meier survival plots. NRS pain scores and symptoms will be analysed using a linear mixed model, with time and group as fixed factors. Multilevel, multivariate analysis will be conducted with different factors including country, gender and number of previous episodes. Results will be documented with p values and 95% confidence intervals.
Data will be analysed using STATA, SAS and/or SPSS software. All tests will be two- sided, and p-value <0.05 will be considered statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/07/2019
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Actual
14/08/2019
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Date of last participant enrolment
Anticipated
30/05/2022
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Actual
26/04/2022
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Date of last data collection
Anticipated
27/06/2022
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Actual
18/05/2022
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Sample size
Target
276
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Accrual to date
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Final
272
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
10354
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New Zealand
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State/province [1]
10354
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Funding & Sponsors
Funding source category [1]
299334
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Commercial sector/Industry
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Name [1]
299334
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Sci-Chem International Pty Ltd
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Address [1]
299334
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Unit 12, 55-57 Newton Rd, Wetherill Park, NSW, 2164.
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Country [1]
299334
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Australia
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Primary sponsor type
University
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Name
Western Sydney University
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Address
NICM Health Research Institute
Locked Bag 1797, Penrith NSW 2751
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Country
Australia
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Secondary sponsor category [1]
298599
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Charities/Societies/Foundations
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Name [1]
298599
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Medical Research Institute of New Zealand
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Address [1]
298599
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Private Bag 7902, Wellington 6242
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Country [1]
298599
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300239
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Western Sydney University Human Research Ethics Committee
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Ethics committee address [1]
300239
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Locked Bag 1797, Penrith NSW 2751
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Ethics committee country [1]
300239
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Australia
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Date submitted for ethics approval [1]
300239
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22/05/2018
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Approval date [1]
300239
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04/07/2018
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Ethics approval number [1]
300239
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H12776
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Ethics committee name [2]
300243
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Northern B Health and Disability Ethics Committee
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Ethics committee address [2]
300243
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Ministry of Health
Ethics Department
Freyberg Building
Reception-Ground Floor
20 Aitken Street
Wellington
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Ethics committee country [2]
300243
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New Zealand
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Date submitted for ethics approval [2]
300243
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30/05/2018
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Approval date [2]
300243
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28/08/2018
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Ethics approval number [2]
300243
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18/CEN/151
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Summary
Brief summary
The aim of this clinical trial is to test the effectiveness of a topical treatment on facial cold sores (herpes simplex labialis): whether it reduces the duration of healing and the amount of pain and other symptoms. A minimum of 292 male and female participants in Australia and New Zealand, aged from 18 to 65 years, will be randomly assigned to receive either a placebo or a medically approved topical treatment. Participants will complete an initial study 'visit' with an investigator either at a pharmacy or by phone. The first visit will be cover an initial assessment and treatment. Participants will report symptoms and healing progression in an on-line daily diary which researchers will monitor for reports of adverse side effects. A second visit will be conducted by phone for comparative assessment once the participant has healed or 14 days have passed.. We expect the primary outcome to be a reduction in the duration of the cold sore compared to the placebo controlled group.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mike Armour
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Address
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Post doctoral Research Fellow,
NICM Health Research Institute
Western Sydney University
Building 22, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
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Country
83018
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Australia
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Phone
83018
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+61 2 4620 3345
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Fax
83018
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+61 2 4620 3291
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Email
83018
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[email protected]
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Contact person for public queries
Name
83019
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Dr Mike Armour
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Address
83019
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Post doctoral Research Fellow,
NICM Health Research Institute
Western Sydney University
Building 22, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
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Country
83019
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Australia
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Phone
83019
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+61 2 4620 3345
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Fax
83019
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+61 2 4620 3291
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Email
83019
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[email protected]
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Contact person for scientific queries
Name
83020
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Dr Mike Armour
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Address
83020
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Post doctoral Research Fellow,
NICM Health Research Institute
Western Sydney University
Building 22, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
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Country
83020
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Australia
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Phone
83020
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+61 2 4620 3345
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Fax
83020
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+61 2 4620 3291
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Email
83020
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Checking standard operating procedures for IPD
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
11561
Informed consent form
[email protected]
11562
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Efficacy of a topical herbal and mineral formulation (Dynamiclear) for the treatment of herpes simplex labialis in the community setting: Study protocol for a randomised, double-blind placebo-controlled trial.
2020
https://dx.doi.org/10.1136/bmjopen-2019-031876
Dimensions AI
Current landscape in antiviral drug development against herpes simplex virus infections
2022
https://doi.org/10.1002/smmd.20220004
N.B. These documents automatically identified may not have been verified by the study sponsor.
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