CompletedNot ApplicableInterventional

Assessing how effective and safe poly-L-lactic acid microsphere injections are for treating male and female pattern hair loss

Hair loss, known as androgenetic alopecia, affects many people and can impact how they feel about themselves. This study is testing a new treatment called Juläine, which is an injectable product containing tiny spheres of poly-L-lactic acid (PLLA). The aim is to see if these injections can safely and effectively help stimulate new hair growth and make existing hair thicker for both men and women experiencing this type of hair loss. Participants will receive three injections over 20 weeks and will be closely monitored. The study will check changes in hair density, hair thickness, and how happy participants are with the results. This research could lead to better treatments for hair loss in the future.

At a glance

Status

Completed

Phase

Not Applicable

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Feb 2025

Treatment of androgenetic alopecia in adult male and female patients experiencing hair thinning and loss due to this condition.

What is this study about?

Hair loss, especially the type known as androgenetic alopecia, is very common in both men and women. It happens when hair follicles on your scalp shrink, leading to thinner hair and eventually hair loss. This can be upsetting and affect how people feel about their appearance and self-confidence. Currently, there are limited effective treatments, and researchers are always looking for new and better ways to help.

This particular study is focusing on a new injectable treatment called Juläine. This product contains tiny particles made from something called poly-L-lactic acid (PLLA). The idea is that when injected into the scalp, these particles might stimulate the scalp in a way that encourages hair follicles to become more active, leading to new hair growth and thicker strands. The study aims to find out if Juläine is both safe to use and whether it actually works to improve hair density and thickness.

By taking part, you could potentially see an improvement in your hair, and your contribution will help doctors understand if this new treatment could be a good option for others experiencing hair loss in the future. The results from this study will be important in deciding if Juläine can go on to be a widely available treatment.

Key takeaways

This study is testing a new injection, Juläine, for common hair loss (androgenetic alopecia).
It aims to see if Juläine can safely make hair thicker and denser.
Participants will have three scalp injections over 20 weeks.
Potential benefits include improved hair appearance; risks include temporary injection site effects.
Your contribution could help improve future hair loss treatments.
The study is taking place in London and funded by Nordberg Medical AB.

Who may be eligible?

This study is looking for men and women between the ages of 20 and 60 who have been diagnosed with a common type of hair loss called androgenetic alopecia. Your hair loss should have been stable for at least six months before you join the study.

However, there are reasons why you might not be able to take part. For example, if you have other types of hair loss, scalp infections, or certain skin diseases. If you've recently used other hair growth treatments like minoxidil or finasteride, or had procedures like PRP therapy in the last six months, you won't be eligible.

Also, if you have certain medical conditions like autoimmune diseases, uncontrolled diabetes, or bleeding disorders, you wouldn't be able to join. Women who are pregnant, planning to get pregnant, or breastfeeding also cannot participate. You also can't be taking part in another clinical trial at the same time or have participated in one very recently.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 20 and 60 years old?
Have you been diagnosed with androgenetic alopecia (male or female pattern hair loss)?
Has your hair loss been stable for at least 6 months?
Have you avoided other hair growth treatments or procedures (like minoxidil, finasteride, or PRP) in the last 6 months?
Are you generally healthy with no major long-term illnesses?
Are you not pregnant, planning pregnancy, or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll need to visit the study clinic at Ouronyx Clinic in London six times over a period of 20 weeks. During your visits, you'll receive three injection sessions of Juläine, with each session spaced four weeks apart. To make the injections more comfortable, the solution includes a numbing medicine (lidocaine).

At your follow-up visits, the study team will carefully check your hair using special cameras to measure hair density and will take photographs of your scalp. You'll also fill out questionnaires to share how you feel about the treatment's effects. You'll get instructions on how to care for your scalp after the injections, and the study staff will be available if you have any questions or concerns. The entire study for each participant will last 20 weeks.

Potential risks and benefits

You might see your hair become thicker and denser, which could boost your confidence and how you feel about your appearance. Even if you don't experience direct benefits, your participation will help doctors learn more about hair loss treatments, potentially leading to better options for others in the future. However, there's no guarantee the treatment will work for you. Possible side effects include temporary redness, swelling, or mild discomfort where the injections are given. In very rare cases, small lumps or other reactions could happen. The study team will watch you closely for any issues, and you are free to leave the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ouronyx
City only
London, United Kingdom

Common questions

What kind of hair loss is this study for?

This study is specifically for a common type of hair loss called androgenetic alopecia, which causes thinning hair in both men and women.

What is Juläine and how is it given?

Juläine is an injectable product containing tiny particles of poly-L-lactic acid. It's injected into the scalp to encourage hair growth, with numbing medicine added for comfort.

How many times will I need injections?

You will receive three injection sessions, each one month apart, as part of the study.

Where does the study take place?

The study is being run from the Ouronyx Clinic in London, UK.

Can I still join if I'm using other hair loss treatments?

No, you cannot if you've used other hair growth treatments or procedures in the last six months. Please discuss all current and past treatments with the study team.

How to find out more

Efthyvoulos Sokratous

thivos.sokratous@ouronyx.com +44 (0)7455007338 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.