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Tests treatment safety and results for Acne
Official title Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
ClinicalTrials.gov ID: NCT06316297
What this study is testing
What is Acne mRNA vaccine?
Acne mRNA vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for acne.
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
- The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE).
- 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...
- Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or...
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- 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; history of a life-threatening reaction to the study interventions used...
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne...
- Use of any acne-affecting treatment without an appropriate washout period
- Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any...
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
- Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie...
- Participants are excluded from the study if any of the following criteria apply:
- 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; any...
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
- Use of any acne-affecting treatment without an appropriate washout period
- Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study...
- Previous vaccination against C. acnes with an investigational vaccine
- 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 participant's...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Cerritos, California, United States
- Encino, California, United States
- La Mesa, California, United States
- Lafayette, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- North Hollywood, California, United States
- Northridge, California, United States
- Oceanside, California, United States
- Oxnard, California, United States
- Palmdale, California, United States
- Pomona, California, United States
- Rolling Hills Estates, California, United States
- San Diego, California, United States
- Santa Rosa, California, United States
- Boynton Beach, Florida, United States
- Coral Gables, Florida, United States
- Cutler Bay, Florida, United States
- Hialeah, Florida, United States
+ 60 more site(s).
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 - 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?
Study sites include Scottsdale, Arizona, United States; Cerritos, California, United States; Encino, California, United States; La Mesa, California, United States; Lafayette, California, United States; Lancaster, California, United States and 74 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.