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.
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.
Wintermute Biomedical
30 participants
Apr 8, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria9
- Male or female aged 18.0 years or older at the time Screening;
- Positive shingles (VZV infection) diagnosis presenting with a minimum of three distinct visible lesions on the torso, trunk, arms, legs, head, or face;
- Participants must have presented with shingles symptoms (lesions/rash) within ten days prior to Screening. This is to avoid including participants whose disease could naturally regress during the trial, which could confound results;
- 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;
- Participants who have had a non-melanoma skin cancer adequately treated within 12 months of screening are permitted to screen for the study.
- 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;
- 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;
- 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;
- Participant is able and willing to provide written, personally signed, informed consent to participate in the study.
Exclusion Criteria17
- Participant is taking opioid pain medication at the time of Screening, or plans to commence opioid pain medication at any time during the study;
- 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;
- 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;
- 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;
- Participant has a current diagnosis of fibromyalgia;
- 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.
- 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;
- 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;
- 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;
- 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;
- 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.
- 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;
- Known anaphylactic hypersensitivity to any of the active ingredients or excipients in Solexan™ or the placebo formulation;
- Planned surgery requiring a general anaesthetic, or surgery requiring inpatient hospitalisation for at least 24 hours from Screening through to Day 30;
- Female participant who is pregnant or breast-feeding, or intends to become pregnant, from Screening through to Day 11;
- 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);
- 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.
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Interventions
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
Locations(1)
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ACTRN12624000075583