Shingles Medical Study
Do you have Shingles? We are recruiting for a medical study investigating the safety and tolerability of a topical product in reducing shingles pain.
What is Shingles?
Shingles is a viral infection that occurs when the varicella-zoster virus, the same virus responsible for 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.
What is the purpose of the study?
The investigational product, Solexan™, has already been registered by the FDA (Food and Drug Administration) as a topical antifungal, and researchers have gathered early-stage evidence that Solexan™ may stop the shingles virus from multiplying. Solexan™ is a topical white foam that can be applied directly to shingles lesions for 10 consecutive days, morning and night.
The purpose of this study is to evaluate the safety and tolerability of this product, its ability to reduce the pain associated with shingles lesions and to gauge the healing response of the lesions.
What is involved?
If you are deemed eligible for the study, your participation is expected to last up to 31 days, and you will be required to attend the study site a minimum of 5 times. This includes:
A site screening visit, which will take about 2 hours
A randomisation and treatment period of 10 days, which includes site visits on Days 1, 5 and 11
A follow-up site visit on Day 30
Maintain a patient diary over the course of the clinical trial
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. A placebo looks like the study medicine but does not contain any study medicine (active ingredient). Researchers use a placebo to see if a study medicine is safer than not taking anything at all. Eligible participants will have a two in three chance of receiving the investigational medication.
Participation in this research is voluntary, and you may withdraw from the study at any time. By participating in this research study, you could potentially help advance medical breakthroughs in the treatment of shingles pain.
Am I eligible for this study?
To take part in this study, you will need to meet all the following:
✅ You are aged 18 or over
✅ You have been diagnosed with shingles (Varicella Zoster Virus), with at least three distinct visible lesions on your torso, trunk, arms, or legs.
✅ You started experiencing shingles symptoms (lesions/rash) within three days of starting the study.
If you meet any of the following criteria, you are ineligible to participate in the study:
❌ You have any *significant infection diagnosis 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 at the planned treatment site (where the shingles lesions are located) - these will be assessed on a case-by-case basis.
For more details on study eligibility, please see Study Eligibility Information.
*Please note: additional eligibility criteria apply and will be discussed during the screening visit.
How can I take part in this study?
If you meet all the study eligibility criteria, you can make an appointment at:
Key Health CBD South
Ground Floor, 281 Elizabeth Street
Sydney NSW 2000
Phone: (02) 8262 1000