Phase
Condition
Rash
Scalp Disorders
Acne
Treatment
Placebo
Acne mRNA vaccine
Clinical Study ID
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, and laboratory tests as judged by theinvestigator
Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator'sGlobal Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones)and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocysticlesions (ie, nodules and cysts)
Exclusion
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within 6 months prior to the first study intervention administration; or long-termsystemic corticosteroid therapy (prednisone or equivalent for more than 2consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the study intervention components (eg,polyethylene glycol [PEG], polysorbate); history of a life-threatening reaction tothe study interventions used in the study or to a product containing any of the samesubstances; any allergic reaction (eg, anaphylaxis) after administration of mRNAcoronavirus disease 2019 (COVID-19) vaccine
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 anystudy intervention administration or planned receipt of any vaccine (other than thestudy vaccine) in the 4 weeks following any study intervention administration
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 potential participation in a clinical trial.
Study Design
Study Description
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