Unfortunately, if any of the following apply to you, this study is not the right fit for you:

• You have any *significant infection other than shingles.
• You are taking any medication or drugs that could impact how your body experiences pain - these will be discussed during screening. 
• You have birthmarks, tattoos, wounds, or other skin blemishes or conditions where the shingles lesions are located - these will be assessed on a case-by-case basis.

*Please note, additional eligibility criteria apply and will be discussed during phone screening with our Patient Experience team. 

Still unsure if this study is suitable for your needs? No worries! Register your interest today for a personalised discussion with our Patient Experience team about your eligibility. 

If you are deemed eligible for the study, your participation is expected to last approximately 31 days, and you will be required to attend the study site up to 5 times. This includes: 

• A site screening visit, which will take about 2 hours.
• Randomisation and a 10-day treatment period, which includes site visits on Days 1, 5 and 11. Participants will be randomised in a 2:1 ratio to receive the investigational product or a placebo. 
• A follow-up site visit on Day 30.
• Over the course of the treatment period, you will be required to apply the investigational product or placebo to the shingles lesions, as well as maintain a diary of your symptoms. 

This is a double-blinded study, which means neither you nor the study doctor will know if you receive the investigational product or a placebo. The placebo looks like the investigational product but does not contain the same active ingredient under investigation.

Researchers use placebos to see what benefits and possible side effects can be attributed to the investigational product. Eligible participants will have a two in three chance of receiving the investigational product.

Participation in this research is voluntary, and you may withdraw from the study at any time.

The purpose of this study is to evaluate the safety and tolerability of the investigational product, Solexan^TM, its ability to reduce the pain associated with shingles lesions, and to gauge the healing response of the lesions. 

Solexan^TM is a white foam that has already been registered by the FDA (Food and Drug Administration) as a topical antifungal, and researchers have gathered early-stage evidence that it may stop the shingles virus from multiplying. It is not currently manufactured for use.

Shingles is a viral infection that occurs when the varicella-zoster virus, the same virus that causes chickenpox, is reactivated and travels along nerve pathways to cause shingles lesions - painful, fluid-filled blisters that typically appear in a band- or strip-like pattern on one side of the face or body.

The pain associated with shingles lesions is often described as a burning, throbbing, or stabbing sensation, and it can persist for weeks if not months after the lesions have healed.

Though the oral antiviral drug Famciclovir  can be used to treat shingles, it must be taken within 72 hours of the first symptom appearing - otherwise, it won’t work as well, and many doctors won’t prescribe this.

However, many patients cannot meet this time frame and so are left with only painkillers for symptom relief. As such, participating in this research study will provide investigators with valuable information about whether Solexan™ is a safe and effective treatment for shingles pain.

This study is sponsored by Wintermute Biomedical, a pharmaceutical company based in Melbourne, Australia, and Missoula, Montana.

Wintermute dedicated its initial decade to researching solutions for drug-resistant infections. They discovered a method to harness the natural germ-fighting properties of fatty acids in common foods.

Collaborating with prestigious institutions like Johns Hopkins Medicine, Public Health England, and the University of Melbourne, Wintermute diligently ensures their solutions prioritise performance to address unmet needs while upholding safety standards for human health and the environment.

Here is a list of all the sites currently recruiting for this study:

• Key Health Sydney CBD Medical Centre:
  • Located in Regency Hyde Park
  • Address: Ground Floor, 281 Elizabeth Street, Sydney NSW 2000, Australia
• Maxwell Medical Group: 
  • Located in: Central West Shopping Centre
  • Address: T22/65-67 Ashley Street, Braybook VIC 3019, Australia

We are here to help you! Click or tap this button to send an email to our dedicated  Patient Experience team:

Contact us

Trial details from ANZCTR.org