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AXON CURRENT STUDIES
PRURIGO NODULARIS:
A clinical research study to evaluate an investigational cream for adults with prurigo nodularis is now enrolling.
Participant Form
Want to participate in a study?
It's easy! Just complete this form and one of our recruiters will contact you to get the process started. |
Who can take part?
You, or someone you care for, may be able to take part if you/they:
About the PN Study
This study is looking at an investigational cream to see if it works to treat people with prurigo nodularis (PN). The study will also look at whether the investigational cream is safe and how well tolerated it is in people with PN.
The investigational cream has been approved in the United States to treat mild-to-moderate atopic dermatitis (also known as “eczema”) and vitiligo in adolescents and adults. However, it has not yet been approved to be used for patients with PN. 
Why is this study important?
PN is a chronic skin condition that causes hard, itchy lumps (lesions) to form on the skin. Itching may be severe and can be constant, or may come and go. For many people, the itching generally starts before the lesions develop, and in some patients with chronic itch, PN occurs as a result of the continuous scratching.
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Screening Period (up to 4 weeks)
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- You will visit the study center once to see if the study is suitable for you and whether you want to take part.
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First study treatment period (DBVC period 12 weeks)
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- You will visit the study center at least 5 times for study assessments.
- You will use the study cream twice every day.
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Screening study treatment Period (OLE period 40 weeks)
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- If you have completed the 12-week DBVC period and there are no problems, you will enter the 40-week OLE period.
- You will visit the study center at least 11 times for study assessments.
- You will use the investigational cream twice every day, unless your PN lesions heal during the OLE period.
- If the OLE period is not suitable for you, you will go straight into the follow-up period.
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Follow up period (30 days)
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- You will visit the study center once for study assessments after you have finished using the study cream
What will this study involve?
If you take part, you will be in the True-PN Study for up to 60 weeks. This study has 2 study treatment periods: the double-blind vehicle- controlled (DBVC) period and the open-label extension (OLE) period.
During the first study treatment period (DBVC), the investigational cream will be compared with a “vehicle cream.” The vehicle cream looks like the investigational cream but contains no active ingredients. You will have an equal chance of receiving either cream. During the second study treatment period (OLE), all participants will receive the investigational cream. Both the investigational cream and the vehicle cream are known as the “study cream.”
During the first study treatment period (DBVC), the investigational cream will be compared with a “vehicle cream.” The vehicle cream looks like the investigational cream but contains no active ingredients. You will have an equal chance of receiving either cream. During the second study treatment period (OLE), all participants will receive the investigational cream. Both the investigational cream and the vehicle cream are known as the “study cream.”
What is a clinical research study?
A clinical research study is a medical study that helps to answer important questions about an investigational medication, such as:
- Does it work?
- Does the amount or dose work?
- How safe is it?
- Are there any side effects?
What else do I need to consider?
- The study team will explain the possible benefits and risks of the study.
- You do not have to take part in the study if you do not want to.
- If you choose to take part in the study, you can stop participating at any time.
- You will be reimbursed for reasonable time and travel costs during your participation.
- All study creams and study-related tests will be provided at no cost to you.
- A team of doctors and nurses will closely monitor your health during the study.
- The study has been approved by an Institutional Review Board (IRB)/Ethics Committee (EC), which protects the rights, safety, and well-being of the participants.
