Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
This study is looking into a new mRNA vaccine designed to treat moderate to severe acne in adults aged 18 to 45. Researchers want to understand if the vaccine is safe to use, how well it works to reduce acne breakouts, and how the body's immune system responds to it. The trial involves giving participants up to three injections at different dose levels to find the most effective and safest option. This is a very early-stage study, aiming to gather enough information before potentially moving on to larger trials. The goal is to develop a new way to prevent and treat stubborn acne.
At a glance
What is this study about?
Acne is a very common skin problem, especially for teenagers and young adults. It affects millions of people worldwide and can significantly impact their lives. Even though it's so widespread, the main ways we treat acne haven't changed much in the last 30 years. There isn't yet a treatment that can safely and effectively prevent or completely clear up acne for everyone.
This study is an important step in trying to change that. Researchers are testing a brand new type of vaccine, called an mRNA vaccine, specifically for acne. You might have heard of mRNA vaccines for other conditions, like COVID-19. The idea behind this acne vaccine is to teach your body to fight off the bacteria or skin processes that cause acne.
The main goals of this study are to find out two key things: first, if the vaccine is safe for people to use, and second, if it actually helps to reduce acne. They'll also be looking at how your immune system reacts to the vaccine. This research will help them decide the best amount (dose) of the vaccine to use if it moves on to bigger studies later. Participants will receive either the active acne vaccine or a placebo, which looks like the vaccine but doesn't contain the active ingredient, to fairly compare its effects.
Key takeaways
- This study is testing a new mRNA vaccine for moderate to severe acne.
- It aims to find out if the vaccine is safe, effective, and how the body reacts to it.
- Participants will be adults aged 18-45 with specific types of acne.
- You might receive the active vaccine or a placebo (dummy injection).
- The study involves multiple injections and follow-up visits, potentially lasting for several years.
- Your general health and specific acne type are important for joining.
Who may be eligible?
To join this study, you need to be an adult between 18 and 45 years old. You should generally be healthy, and a doctor will check this through a medical history, examination, and some tests.
Your acne needs to be considered 'moderate' or 'severe' by the study doctors. This means you'll have a certain number of spots, including blackheads, whiteheads, red bumps, and pus-filled spots. You should not have severe nodular or cystic acne, or other unusual forms of acne.
There are also reasons you might not be able to join. For example, if you have a condition that weakens your immune system, or you've recently had certain medical treatments like chemotherapy or long-term steroid use. You also shouldn't have had a severe allergic reaction to any vaccine, especially an mRNA vaccine like some COVID-19 vaccines, or to any of the ingredients in the study vaccine. You'll need to pause certain acne treatments before joining, and you shouldn't have plans to receive other vaccines close to the study vaccine dates.
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 18 and 45 years old?
- Do you have moderate to severe acne (not extremely severe or unusual types)?
- Are you generally healthy, without conditions that weaken your immune system?
- Have you avoided certain acne treatments or specific other vaccines recently?
- Do you not have a known severe allergy to vaccines, especially mRNA vaccines?
What does participation involve?
If you decide to take part, you'll be part of the 'Core Study'. This involves receiving up to three injections of either the acne mRNA vaccine or a placebo (a dummy injection). These injections will be given into a muscle, likely in your arm. There will be different groups in the study, some receiving two injections and others three, over a set period.
Throughout the study, you'll have regular visits to the clinic so doctors can check your health, see how your skin is responding, and monitor for any side effects. They'll also take blood samples to see how your body is reacting to the vaccine. After you finish the main part of the study, you might be invited to continue in an 'optional Long-Term Extension'. This means you'd have follow-up visits for up to 30 more months to see if the vaccine has long-lasting effects. The exact number of visits, tests, and the total duration will depend on which group you're in and whether you join the long-term follow-up, but it will be thoroughly explained to you.
Potential risks and benefits
Locations (93)
- Center for Dermatology and Plastic Surgery- Site Number : 8400111Verified postcodeScottsdale, United States· Recruiting
- Private Practice - Dr. Francisco Badar- Site Number : 8400067Verified postcodeCerritos, United States· Recruiting
- Encino Research Center- Site Number : 8400033Verified postcodeEncino, United States· Recruiting
- Paradigm Clinical Research Centers- Site Number : 8400064Verified postcodeLa Mesa, United States· Recruiting
- Sunwise Clinical Research- Site Number : 8400108Verified postcodeLafayette, United States· Recruiting
- Chemidox Clinical Trials- Site Number : 8400075Verified postcodeLancaster, United States· Recruiting
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058Verified postcodeLos Angeles, United States· Recruiting
- LA Universal Research Center- Site Number : 8400059Verified postcodeLos Angeles, United States· Recruiting
- Alliance Clinical - West Hills- Site Number : 8400131Verified postcodeLos Angeles, United States· Recruiting
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400076Verified postcodeNorth Hollywood, United States· Recruiting
- Northridge Clinical Trials - Northridge- Site Number : 8400053Verified postcodeNorthridge, United States· Recruiting
- Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099Verified postcodeOceanside, United States· Recruiting
Common questions
What is an mRNA vaccine?
An mRNA vaccine teaches your body's cells to make a harmless piece of a protein. This protein then triggers your immune system to create antibodies, preparing your body to fight off the actual disease or problem, in this case, acne.
Will I definitely get the acne vaccine, or might I get a placebo?
Because this is a research study, you might receive the active acne vaccine or a placebo (a dummy injection that looks the same but contains no active medicine). This helps researchers fairly compare the effects of the vaccine.
How long will the study last if I join?
The main part of the study involves several injections and regular check-ups. After that, you might be invited to a long-term follow-up portion, which could last for up to 30 months, to see the longer-term effects.
What kind of acne does this study focus on?
This study is for adults with moderate to severe facial acne that includes blackheads, whiteheads, red bumps, and pus-filled spots. It's not for very severe nodular/cystic acne or other specific types of acne.
Can I leave the study if I change my mind?
Yes, absolutely. Participating is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your normal medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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