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
Connect with a study center
Encino Research Center Site Number : 8400033
Encino, California 91436
United StatesActive - Recruiting
True Blue Clinical Research Site Number : 8400016
Brandon, Florida 33511
United StatesSite Not Available
Jacksonville Center for Clinical Research Site Number : 8400006
Jacksonville, Florida 32216
United StatesActive - Recruiting
Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida 32216
United StatesActive - Recruiting
True Blue Clinical Research- Site Number : 8400016
Tampa, Florida 33609
United StatesActive - Recruiting
Alliance for Multispecialty Research Site Number : 8400019
Oakbrook Terrace, Illinois 60181
United StatesActive - Recruiting
Accellacare of McFarland Site Number : 8400045
Ames, Iowa 50010
United StatesActive - Recruiting
Louisiana Dermatology Associates LLC, DelRicht Research at LA Dermatology Associates Site Number : 8400043
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
DelRicht Research Site Number : 8400013
New Orleans, Louisiana 70115
United StatesActive - Recruiting
Metro Boston Clinical Partners Site Number : 8400008
Brighton, Massachusetts 02135
United StatesActive - Recruiting
DermResearch Center of New York, Inc Site Number : 8400010
Stony Brook, New York 11790
United StatesSite Not Available
Lynn Health Science Institute (LHSI) Site Number : 8400004
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Lynn Health Science Institute (LHSI)- Site Number : 8400004
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Best Skin Research, LLC Site Number : 8400017
Camp Hill, Pennsylvania 17011
United StatesActive - Recruiting
Vial Health @DermDox Dermatology Site Number : 8400017
Camp Hill, Pennsylvania 17011
United StatesActive - Recruiting
Dermresearch Site Number : 8400009
Austin, Texas 78759
United StatesSite Not Available
Center for Clinical Studies, LTD. LLP Site Number : 8400002
Houston, Texas 77004
United StatesActive - Recruiting
Center for Clinical Studies, LTD. LLP- Site Number : 8400002
Houston, Texas 77004
United StatesActive - Recruiting
DelRicht Research at Lockhart Matter Dermatology Site Number : 8400046
Prosper, Texas 75078
United StatesActive - Recruiting
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