There are different places where you might find out about a clinical trial happening for alopecia, including from your doctor, adverts on social media, or through the Alopecia UK website. Anyone could in theory take part in clinical research, however whether you are able to take part in a particular trial depends on its inclusion and exclusion criteria. This section gives some examples of typical criteria used in alopecia clinical trials, and goes on to describe what to expect if you decide to sign up for one.

Can I take part?

Before signing up for a trial, you may be asked screening questions about yourself to see if you are eligible. Some examples of screening criteria that are used in alopecia clinical trials include:

• Severity (and type) of hair loss

For alopecia areata, the words mild, moderate, and severe are used to describe the severity. In terms of percentage of scalp hair loss, mild means 1-20%, moderate means 21-49%, and severe means 50% or more. People with total scalp and total body hair loss commonly use the terms alopecia totalis and alopecia universalis to describe their own hair loss severity. These forms are typically included in severe alopecia areata.

For male pattern hair loss, the Hamilton-Norwood scale is used to give a severity score from I to IV. For female pattern hair loss, the Ludwig scale is most commonly used to give a severity score from I to III.

For scarring alopecias, severity of hair loss is not typically part of the criteria, as the highest priority is stopping the scarring. For this they can assign a score to the redness and scaling around hair follicles (perifollicular erythema and scaling) to assess the severity. Other indicators may be used depending on the type of scarring alopecia. 

• Current episode of hair loss

Episode means the period of active hair loss. For example, if you first developed alopecia areata at a younger age, then had full regrowth, and started losing hair again 2 years ago – your current episode would be 2 years.

• Time since diagnosis

The time since you were first diagnosed with alopecia by a doctor. Trials for alopecia areata may require that you have been diagnosed some time in the past. This is because spontaneous regrowth may be more likely if the disease is new, which then would make it hard to know if the regrowth was due to the treatment or would have happened anyway.

• Pregnancy

Typically, you will not be able to take part if you or your partner are pregnant or are planning to become pregnant. You may also be asked to use contraception for the trial period. This is because many treatments are not safe to use during pregnancy. 

• Refrain from changing hairstyles or shaving

Typically, trials testing treatments for hair growth will ask you not to make any changes to your hair yourself, so that they can see what the treatment is doing to your hair growth. This could mean that you can’t shave your hair for several weeks before, and during, the trial.

• Other treatments

If you are currently taking or have recently finished taking another treatment, you may not be able to take part. Usually, you need to not be receiving any other treatment at the time of signing up for the trial. In some cases you may not be able to take part if you have taken another treatment within several months of signing up.

The above criteria are examples of ones which may be used in clinical trials for alopecia. The actual inclusion and exclusion criteria are set by the investigators and are listed in the Participant Information Sheet (PIS) for each trial. This is a document that is given to you by the research team, when you express interest in a clinical trial. You may find out through the screening process or upon reading the PIS that you are not able to take part in a clinical trial that you wanted to, which understandably can be very disappointing. However, we all want there to be treatments for everyone that needs them, which means they need to be tested first, so there may be other trials in the future that you can take part in.

What should I expect from a clinical trial?

If you decide you are interested, and you are eligible, you will be asked to provide informed consent. This term describes a process that enables you to fully understand what the trial is about, how it will work, and what you will be asked to do. You will be given a Participant Information Sheet (PIS) to read at home. This is a document that tells you everything you will need to know about the trial, including things like: the purpose of the study, how many visits you will need to make, what to do if something goes wrong, and how your data is processed. Make sure you carefully read through all of the information and ask the investigators questions about anything that is not clear. You should never feel under any pressure to take part in a clinical trial, it is your own decision.

Taking part in a clinical trial can be a big step, and it is important that you fully understand what impact it will have on your day-to-day life. The trial could last several months, or maybe even more than a year. It could be a good idea to discuss taking part in the trial with your family, partner and/or friends, so that they can support you as you go through it. You can also bring someone along to your visits if that would be helpful for you.

The hope with any new treatment is that it can help improve symptoms. But it is important to understand that there can be different outcomes to a clinical trial. The aim of the trial is to see if the treatment is safe and effective. However, everyone is different, and so what works for one person may not work for another. It could lead to your hair regrowing, but it is also possible that the treatment does not work as was hoped. There is also a chance that you will receive a placebo (dummy) treatment, which does not have any of the active ingredient. Additionally, there is a risk of side effects arising from the treatment. However, the PIS will explain the processes in place to minimise the risk, and during the trial the investigators will regularly check-up on you to see how you are doing.

You will need to weigh up the risks and benefits to decide if taking part is worth it for you. If you decide to go ahead, you will be asked to sign the Consent Form, which confirms that you are happy to take part. If at any point during the research you decide you no longer wish to take part, even after you have already given consent, you are always free to withdraw without any repercussions.

You should also know that any information collected during the trial will be kept confidential, and when the results are published, this will be anonymous, so no one will be able to identify you. Clinical trials need to be approved by a Research Ethics Committee, to ensure everything that happens is fair and ethical. The Participant Information Sheet has information on who has reviewed the study and who to contact if you have any concerns.

Sometimes, the researchers will ask to take biological samples (blood, biopsies) before and after treatment, to study how the treatment affects inflammatory and immune mechanisms involved in the disease. This lets them learn more about what’s causing the disease and can be used to optimise treatment in the future. However, usually this is optional, so you can still take part if you do not wish to have samples taken. 

What happens after the trial ends?

If the trial is a success, it is likely you will want to keep taking the treatment. However, this may not always be possible. Stopping the treatment may mean that you experience a relapse in symptoms, including losing your hair again if it had regrown. While we of course wish for treatments that can bring lasting improvements, in reality, most treatments will require that you keep taking them for continued success. It is important to be aware of this so that you can manage the psychological challenges this may bring.

For people that received the placebo treatment, it may be possible to switch to the real treatment after trial ends. There may also be an extension phase which follows people for a longer time, which could mean you can keep receiving the treatment. However, it is also possible that nothing further happens after the trial ends. The Participant Information Sheet, or the clinical trial researchers, will be able to tell you what will happen after the trial.

It is also possible that the trial is not a success, for example because the treatment is not effective enough, or causes too many side effects. While it may be disappointing to think that no new treatment has been found, it is still important that this evidence was collected by doing a trial, as without it we would not have known. Plus, even treatments that don’t work can teach us about mechanisms that may or may not be involved in the disease.

Once the results have been analysed by the researchers, everyone who took part should receive a summary of these results. The researchers should also publish the results in a scientific journal and may present them at conferences to other researchers and doctors.

Why should I take part in a clinical trial?

We don’t yet know what triggers or causes most forms of alopecia. However, researchers are starting to understand more and more about what processes in the body are involved. The discovery that JAK inhibitors can lead to hair regrowth was a breakthrough moment for people with alopecia areata. Before these treatments were approved for use in alopecia areata, clinical trials for JAK inhibitors showed they were effective at regrowing hair in hundreds of people, without causing serious side effects. However, JAK inhibitors are not a cure, they do not work for everyone, and we don’t yet know about their long-term effects. And, there are still no approved treatments for scarring alopecias, and some other forms of alopecia. It is important that more treatments become available to give everyone with alopecia a viable treatment option. By taking part in a clinical trial, you can:

• Help find new treatment options for yourself and others like you with alopecia.
• Better understand your own condition.
• Access potential new treatments before they become available widely.
• Help researchers better understand alopecia, which could improve care for future generations.

Researchers rely on people with alopecia to take part in clinical trials so that they can find better ways to treat these conditions.

For more information: 

• What is a clinical trial?
• Active alopecia clinical trials