Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris

Key Inclusion Criteria:

• Male or female at least 9 years of age and older.

• Written and verbal informed consent must be obtained. Participants less than age ofconsent must sign an assent for the study and a parent or a legal guardian must signthe informed consent (if participant reaches age of consent during the study theyshould be re-consented at the next study visit).

• Participants must be willing to comply with study instructions and return to the studycenter for required visits. Participants under the age of consent must be accompaniedby the parent or legal guardian at the time of assent/consent signing.

• If a cleanser, moisturizer or sunscreen is needed during the study, participants mustbe willing to use only allowed cleansers, moisturizers, sunscreens, ormoisturizer/sunscreen combination products. If the participant wears makeup they mustagree to use non-comedogenic makeup.

Key Exclusion Criteria:

• Use of an investigational drug or device within 30 days of enrollment or participationin a research study concurrent with this study.

• Any dermatological conditions on the face that could interfere with clinicalevaluations such as acne conglobata, acne fulminans, secondary acne, perioraldermatitis, clinically significant rosacea, gramnegative folliculitis.

• Any underlying disease(s) or some other dermatological condition of the face thatrequires the use of interfering topical or systemic therapy or makes evaluations andlesion count inconclusive.

• Participants with a facial beard or mustache that could interfere with the studyassessments.

• History of hypersensitivity or allergic reactions to any of the study preparations asdescribed in the Investigator's Brochure, including known sensitivities to any dosageform of tretinoin.

• Participants who are unable to communicate or cooperate with the Investigator due tolanguage problems, poor mental development, or impaired cerebral function.

• Participants with any underlying disease that the Investigator deems uncontrolled, andposes a concern for the participant's safety while participating in the study.