Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000075583
Ethics application status
Approved
Date submitted
18/12/2023
Date registered
30/01/2024
Date last updated
23/05/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
WNTR-VZV-001: A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Solexan™ when Administered Topically to Acute Varicella Zoster Virus (Shingles) Lesions.
Scientific title
WNTR-VZV-001: A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Solexan™ (arginine undecylenate) when Administered Topically to Acute Varicella Zoster Virus (Shingles) Lesions.
Secondary ID [1] 311056 0
Wintermute Biomedical WNTR-VZV-001
Universal Trial Number (UTN)
U1111-1300-9952
Trial acronym
ZOSTER EASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shingles 332175 0
Herpes Zoster 332176 0
Condition category
Condition code
Infection 328893 328893 0 0
Other infectious diseases
Skin 328894 328894 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arginine undecylenate for topical application.

The study is designed to evaluate the safety and tolerability of arginine undecylenate (15.7% w/w undecylenic acid (arginine undecylenate)) and to explore its effectiveness in mitigating the pain associated with the cutaneous lesions that present as a result of VZV infection (shingles).

Up to a total of 30 eligible participants will be randomly assigned in a ratio of 2:1 to receive either arginine undecylenate (n=20) or placebo (n=10) twice daily for 10 consecutive days. At each dosing time point, an IP amount sufficient to completely cover the shingles lesions and surrounding skin, but not exceeding 10 full pump strokes, will be administered. The area of skin affected by shingles lesions may vary significantly between participants and the lesions can sometimes be spread over a large area of skin. Further, the surface area of skin covered by one pump stroke of IP may vary considerably based on the pain associated with the lesions i.e., participants with extremely painful lesions may spread the foam less than participants with only moderately painful lesions to avoid pain during application. Therefore, the number of pump strokes administered per dose will be determined on a per-participant basis by the participant and documented in the participant diary. A maximum of 20 pump strokes per 24-hour period should not be exceeded. The number of pump strokes administered per dose may vary at the participant’s discretion as the size of the lesion field and/or associated pain intensity varies over the 10-day treatment period.

Participants will self-administer arginine undecylenate or placebo twice daily at home from Day 1/2 through Day 10/11 and the treatments will be recorded in the participant diary.

Dose: 55 mg - 706.5 mg undecylenic acid twice daily
Duration: 10 days
Mode of administration: topical
Intervention code [1] 327503 0
Treatment: Drugs
Comparator / control treatment
Topical Placebo of identical appearance; a commercially available baby sanitiser: Kids Bliss Alcohol-Free Foaming Hand Sanitiser, Unscented, containing purified water, coco betaine, citrus pulp extract, citric acid, lactic acid, and glycerin.

Dose: 0 mg undecylenic acid twice daily
Duration: 10 days
Mode of administration: topical
Control group
Placebo

Outcomes
Primary outcome [1] 336706 0
To evaluate the safety and tolerability of 10 days of topical administration of arginine undecylenate in adults with acute shingles lesions.
Timepoint [1] 336706 0
AE review by physician, patient diary completion and patient accountability logs with scales to weight use of IP.
Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 and Day 30 post-intervention commencement.
Secondary outcome [1] 429378 0
To evaluate whether 10 days of topical administration of arginine undecylenate causes a change in pain associated with shingles lesions.
Timepoint [1] 429378 0
Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11 and Day 30 post-intervention commencement.
Secondary outcome [2] 429379 0
To evaluate whether 10 days of topical administration of undecylenic acid changes healing of shingles lesions.
Timepoint [2] 429379 0
Day 1 Day 5, Day 11 and Day 30 post-intervention commencement.
Secondary outcome [3] 430587 0
To evaluate whether 10 days of topical administration of undecylenic acid to shingles lesions impacts quality of life.
Timepoint [3] 430587 0
Day 1, Day 5, Day 11, and Day 30 post-intervention commencement.

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible for this study:
1) Male or female aged 18.0 years or older at the time Screening;
2) Positive shingles (VZV infection) diagnosis presenting with a minimum of three distinct visible lesions on the torso, trunk, arms, or legs;
3) Participants must have presented with shingles symptoms (lesions/rash) within five days prior to Screening. This is to avoid including participants whose disease could naturally regress during the trial, which could confound results;
4) Be in otherwise good health, as determined by satisfactory medical history, physical examination and vital signs, at the discretion Investigator. Participants with stable, chronic underlying illnesses such as psychiatric/psychological disorders, hypertension, diabetes, ischemic heart disease or hypothyroidism (or other conditions as per Investigator’s discretion) may be enrolled provided their signs and symptoms are controlled and are not expected to interfere with study results. If on regular prescription medication, the medication dose must have been stable for at least one months prior to Screening, with the exception of contraceptive medications which must have been stable for at least three months prior to Screening;
5) Participants who have had a non-melanoma skin cancer adequately treated within 12 months of screening are permitted to screen for the study.
6) Participants of childbearing potential must return a negative urine pregnancy test at pre dose on Day 1 and must agree to remain sexually abstinent, use medically effective contraception or have a partner who is sterile or same-sex, from Screening through to Day 11. Post menopausal participants can be included, and are defined as those with at least 12 months since their last menstrual period;
7) Non-surgically sterilised, sexually active male participants with a female partner of child-bearing potential must agree to use condoms, together with medically effective contraception for their female partner through to Day 11;
8) Participant is able to communicate effectively with study personnel and is considered likely to be reliable, willing and cooperative in terms of compliance with the protocol requirements;
9) Participant is able and willing to provide written, personally signed, informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following exclusion criteria will not be eligible for this study:
1) Participant is taking opioid pain medication at the time of Screening, or plans to commence opioid pain medication at any time during the study;
2) Participants with shingles lesions presenting on the facial area – including upper face, middle face, and lower face.
3) Participant is taking topical or oral steroidal anti-inflammatories at the time of Screening, or plans to commence topical or oral steroidal anti-inflammatories at any time during the study;
4) Participant is currently using Nervoderm lignocaine (5% w/w) dermal patch or any other lidocaine-containing dermal preparations at the time of Screening, or plans to commence using Nervoderm lignocaine patch or any other lidocaine-containing dermal preparations at any time during the study;
5) Participant is suffering from mental illness, including dementia-related cognitive decline that may, in the Investigator’s opinion, make study compliance challenging, confound the results of the study, or interfere with pain reporting;
6) Participant has a current diagnosis of fibromyalgia;
7) Participant is engaged in recreational drug use that may bias the pain scale reporting, particularly cannabinoid or endocannabinoid use, at the discretion of the Investigator. Participants must return a negative urine drug and alcohol screen at pre-dose on Day 1 to be eligible for randomisation.
8) Participant is taking tricyclic antidepressants which are demonstrated to reduce neuropathic pain at the time of Screening or plans to commence use at any time during the study. Participants must return a negative urine drug of abuse & alcohol screen at pre-dose on Day 1 to be eligible for randomization;
9) Participant is taking anticonvulsant drugs i.e. gabapentin or pregabalin, which are demonstrated to reduce neuropathic pain at the time of Screening or plans to commence use at any time during the study;
10) Participant demonstrates evidence of other clinically significant active infection(s) that in the Investigator's opinion would interfere with the study conduct or its interpretation. Potential participants with human immunodeficiency virus (HIV) are ineligible; participants with hepatitis B or C are not specifically excluded and may be enrolled at the discretion of the Investigator;
11) Use of any investigational drug or device within 30 days, or five half-lives of the drug (whichever is longer) before Day 1, or planned use of another investigational drug or device at any time during the study;
12) Participant has a known cancer diagnosis and is currently receiving or has received anti-cancer therapy within 12 months of Screening; Important: Participants who have had a non-melanoma skin cancer adequately treated within 12 months of screening are permitted to screen for the study.
13) Participant has birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair, or other skin conditions including psoriasis, eczema, or dermatitis, at the planned treatment site that, in the Investigator’s opinion, may obscure the observation and assessment of the treatment site;
14) Known anaphylactic hypersensitivity to any of the active ingredients or excipients in Solexan™ or the placebo formulation;
15) Planned surgery requiring a general anaesthetic, or surgery requiring inpatient hospitalisation for at least 24 hours from Screening through to Day 30;
16) Female participant who is pregnant or breast-feeding, or intends to become pregnant, from Screening through to Day 11;
17) A history of alcohol abuse in the past 12 months, or current declared alcohol consumption >4 standard drinks per day for 7 days per week (one standard drink is equivalent to 285 mL of full-strength beer, 100 mL of wine or 30 mL of spirits);
18) An employee, or a first-degree family member of an employee, of the Sponsor, Contract Research Organization conducting this study, or study site involved in this study.

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)
Central randomisation with 1 kit consisting of 2 bottles allocated per patient for the life of the study conduct.
Allocation was concealed by using numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation - Interactive Web Randomisation System (IWRS)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Sample Size:
The proposed sample size is 20 active participants and 10 placebo participants, totalling 30 participants overall. The sample size was based on empirical considerations and no formal sample size calculation was performed.

Statistical Analyses:
Four analysis datasets will be used for study data analyses: Intention-to-Treat (ITT) Set, Safety Set, modified ITT (mITT) Set and the Per-Protocol (PP) Set.
All data will be summarised by treatment group and time point unless stated otherwise.
The general analytical approach for all data will be descriptive in nature. Continuous variables will be described using the number of non-missing values, mean, standard deviation (SD), median, minimum, and maximum. Categorical variables will be described using frequency counts and percentages per category. Exploratory inferential analyses may be performed to assess the difference between arginine undecylenate and placebo, however it is acknowledged that the study is not formally powered to support hypothesis testing.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
8/04/2024
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 42342 0
2000 - Sydney
Recruitment postcode(s) [2] 41729 0
3019 - Braybrook

Funding & Sponsors
Funding source category [1] 315313 0
Commercial sector/Industry
Name [1] 315313 0
Wintermute Biomedical
Country [1] 315313 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Wintermute Biomedical
Address
Level 4, 60 Moorabool Street, Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 317366 0
None
Name [1] 317366 0
Address [1] 317366 0
Country [1] 317366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314236 0
Bellberry Limited
Ethics committee address [1] 314236 0
123 Glen Osmond Road Eastwood SA 5063
Ethics committee country [1] 314236 0
Australia
Date submitted for ethics approval [1] 314236 0
15/11/2023
Approval date [1] 314236 0
18/12/2023
Ethics approval number [1] 314236 0

Summary
Brief summary
This study is designed to evaluate the safety and tolerability of arginine undecylenate (15% w/w undecylenic acid) and to explore its effectiveness in mitigating the pain associated with the lesions that present as a result of VZV infection (shingles). Up to a total of 30 eligible participants will be randomly assigned in a ratio of 2:1 to apply either arginine undecylenate (n=20) or placebo (n=10) to their shingles lesions twice daily for 10 consecutive days. The Zoster Brief Pain Inventory (ZPBI) will be completed by the participant throughout the study. Participants will return to the clinic on Day 5, Day 11, and Day 30 for safety review and preliminary efficacy assessments.
Trial website
https://www.maxwellmedical.com.au/clinical-trials
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130894 0
Dr Euan Mabon
Address 130894 0
Maxwell Medical Group, Central West Shopping Centre, T22/65-67 Ashley Street, Braybrook, VIC 3019
Country 130894 0
Australia
Phone 130894 0
+61 03 7036 2450
Fax 130894 0
Email 130894 0
emabon@maxwellmedical.com.au
Contact person for public queries
Name 130895 0
Dr Euan Mabon
Address 130895 0
Maxwell Medical Group, Central West Shopping Centre, T22 at 65-67 Ashley Street, Braybrook, VIC 3019
Country 130895 0
Australia
Phone 130895 0
+61 03 7036 2450
Fax 130895 0
+61 03 7036 2450
Email 130895 0
emabon@maxwellmedical.com.au
Contact person for scientific queries
Name 130896 0
Dr Alyce Mayfosh
Address 130896 0
Wintermute Biomedical Australia, Level 4, 60 Moorabool Street, Geelong VIC 3220
Country 130896 0
Australia
Phone 130896 0
+61 03 4250 9750
Fax 130896 0
Email 130896 0
alyce.mayfosh@wintermutebiomedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.