Hidradentitis suppurativa (HS) is a challenging skin condition that causes lesions and abscesses. Although doctors have various treatment options to reduce symptoms, these strategies don’t always work well for everyone. Fortunately, people with HS can participate in research studies, called clinical trials, to help discover more about HS and try the latest treatments under development.

Members of myHSteam have expressed their concerns about clinical trials. “I have been getting emails from clinical trials for HS, but I’m scared even to participate because the drug is new, and I do not want to be the one to confirm the bad side effects the medicine could potentially have 🫣😭. Would you participate in a trial study?” asked one member.

Understanding how clinical trials work can help you decide whether to pursue them further. Here are the basic facts about clinical trials for HS.

1. You May Benefit From Participating in a Clinical Trial for Hidradenitis Suppurativa

When you participate in a clinical trial, you may gain access to new treatments in development, new combinations of medications, or existing therapies under review for new types of use. Some clinical trials don’t test new drugs but instead evaluate ways to improve HS management, overall health, or comorbidities (coexisting conditions).

The treatment being studied is called an investigational drug or therapy. Every existing treatment has gone through a clinical trial, and some participants had early access to new therapies.

There are clinical trials for people with mild HS and those with a moderate to severe form of the condition. Some studies focus on younger people, and others are limited to older age groups. Joining a clinical trial may benefit you and can help people with HS in the future. Joining helps ensure that people of your race, age, or ethnic background are included in skin disease research.

2. Clinical Trials Investigate New Treatments

The specific goals of clinical trials vary, but researchers are looking for more effective ways to treat HS and improve the quality of life for those living with the disease.

Research studies often seek answers to these types of questions:

• Is a new medication safe and effective?
• What dosage of an existing or new medication works best?
• Is a new treatment better than existing treatments?
• Does a new treatment cause fewer side effects than existing treatments?
• Does a new treatment help people who haven’t responded to other treatment options?

Current HS-specific clinical trials examine a wide range of topics, including treatment options like low-dose radiation and botulinum toxin (Botox) injections, mental health support with mindfulness programs, and discovery of the root causes of HS. You can look for studies on ClinicalTrials.gov or ask your health care provider if they know about any trials that might be a good fit.

3. You’ll Be Told if You Might Get a Placebo

A placebo, sometimes called a “sugar pill,” is designed to look like the treatment being studied but doesn’t have any active ingredients. Clinical trials may assign a group of participants a placebo to compare results with test groups. In every clinical study, researchers inform participants if there’s a chance they might receive a placebo rather than the treatment under study.

Placebos may also be used when a clinical trial tests an existing treatment in combination with a new one. One group of participants might receive the existing treatment plus a placebo, and another group would receive the existing treatment in combination with the investigational drug or therapy. This type of study is called a placebo-controlled trial.

In most trials, the group that receives the investigational treatment versus the group that takes a placebo — or existing treatment — is decided randomly to avoid bias. This process is called randomization. Many research studies are also double-blind, also called masked, meaning neither the trial participants nor the researchers know which participants are receiving which treatment until the trial is over.

In some clinical trials, if the investigational treatment appears to be much more effective than the treatment it’s being compared to, the new treatment may be made available to all participants at some point in the study.

One myHSteam member shared their experience considering joining a trial: “The doctor wants me to join a clinical trial for biologics. A pro of participating is that I would eventually get free treatment. I could be in the placebo group but would get the drug after the trial. But the downside is that I’m scared of side effects.”

Understanding the trial terms, including whether there will be placebo groups and if you’ll get access to the trial drug later, can help you feel prepared and know what you’re agreeing to.

4. Your Safety Will Be Protected All Along the Way

The safety of participants is a priority in clinical trials, so safeguards are in place. These protections were carefully developed in response to historical wrongdoings in which individuals’ rights were not maintained in medical research.

Clinical trials in the United States are overseen by the U.S. Food and Drug Administration (FDA), which is mandated by law to protect human safety. Other regulatory boards serve a similar function in countries around the world.

Institutional Review Board

In the United States, an ethical body called an Institutional Review Board (IRB) approves and monitors the majority of clinical trials. IRBs review studies to ensure that the potential benefits are significantly greater than the risks and that appropriate precautions are in place to protect participants. If it is determined during the trial that it is no longer safe, the study will be stopped.

Informed Consent

Before joining a research study, you will be given thorough information about the goals of the trial and potential risks for participants. Clinical trials are required to help you make an educated decision about volunteering in a study. This process is called informed consent.

All treatments, including approved therapies, have potential risks of side effects. Clinical trials are carefully designed to minimize risks. Participants in clinical trials are closely monitored to determine if a treatment is safe and if the potential benefits outweigh the potential risks. The informed consent process gives you plenty of time to ask questions and consider whether you’re comfortable with the study before you join. This process allows you to discuss the trial with your doctor, family members, and others you rely on for advice.

You’ll also be given general information about the research study, such as how much time will be required, any costs, what kind of travel may be involved, and what any medical procedures will involve. Costs for clinical trials are usually covered by the company or organization sponsoring the trial, along with health insurance.

There are different phases of clinical trials. Phase 1 trials focus primarily on the safety, dosage, method of taking treatment, and side effects of the investigational therapy. Phase 2 and phase 3 trials recruit larger numbers of participants and focus on how well a treatment works in addition to its safety.

5. You Can Change Your Mind at Any Point

You have the right to leave a research study at any time for any reason, even if it’s still in progress. Signing consent documents and agreeing to participate isn’t a contract that requires you to stay in the trial if you want to stop.

If you decide to leave a clinical study, let the research staff know so that you can be formally withdrawn. Depending on the trial, you may need to undergo monitoring when discontinuing study treatment. If you’re considering withdrawing, reach out to the study team or your doctor first so you can discuss questions or concerns.

6. You Might Be Able To Continue Your Current Treatment

Participating in a clinical trial doesn’t necessarily mean you have to stop using HS treatments that are working for you. It will depend on the requirements of the trial. While participating in a clinical trial, most people still follow up regularly with their usual dermatology providers.

The medical care you receive as part of the trial doesn’t replace comprehensive health care. Your doctors can coordinate with the research team to help ensure that the clinical trial treatment is compatible with any other medications you’re taking. Your dermatologist can help you understand how participating in a research study might affect your care.

Talk With Others Who Understand

On myHSteam, the social network for people and their loved ones living with hidradenitis suppurativa, more than 41,000 members come together to ask questions, give advice, and share their stories with others who understand life with HS.

Have you considered a clinical trial for the treatment of hidradenitis suppurativa? Would you prefer to find studies on a new biologic therapy or lifestyle intervention? Share your experience in the comments below, or start a conversation by posting on your Activities page.