Acne study: Acne mRNA vaccine
Official title Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
ClinicalTrials.gov ID: NCT07013747
What this study is testing
What is Acne mRNA vaccine?
This is an investigational injectable medicine being studied as a potential treatment for mild acne. is designed to use mRNA technology to help the body's immune system respond to acne-causing factors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether an acne mRNA vaccine is safe and how well it works. It also looks at the body’s immune response to the vaccine.
- Who it's for
- You may be able to join if you are 18 to 45 years old and have mild acne.
- What's involved
- You would receive two shots of the vaccine. You will have check‑ins to see how you feel and to measure safety. If you agree, you could stay in the study for up to 30 months after the last visit to see long‑term effects.
- Time commitment
- The core part of the study lasts about a year with several visits, and an optional extension could add up to 30 more months of follow‑ups.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as...
- IGA score of mild (grade 2 on the 5-grade IGA scale) AND
- between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
- between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
- no nodulocystic lesions (ie, nodules and cysts)
You likely can't join if
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation...
- Known systemic hypersensitivity to any of the study intervention components
- Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
- Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of...
- Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's...
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
See the full eligibility criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
- IGA score of mild (grade 2 on the 5-grade IGA scale) AND
- between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
- between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
- no nodulocystic lesions (ie, nodules and cysts)
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention...
- Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
- Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
- Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema...
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus The above information is not intended to contain all considerations relevant to a patient's...
The study team makes the final eligibility decision.
Where it is enrolling
- Encino, California, United States
- Brandon, Florida, United States
- Jacksonville, Florida, United States
- New Orleans, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Encino, California, United States; Brandon, Florida, United States; Jacksonville, Florida, United States; New Orleans, Louisiana, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.