Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: IDP 121 Lotion; IDP-121 Vehicle Lotion
Intervention description: IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.; IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the efficacy, safety, and tolerability of a once
      daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle
      Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an
      Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
    

Eligibility criteria:

        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 of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if participant reaches age of consent during the study they
             should be re-consented at the next study visit).

          -  Participants must be willing to comply with study instructions and return to the study
             center for required visits. Participants under the age of consent must be accompanied
             by the parent or legal guardian at the time of assent/consent signing.

          -  If a cleanser, moisturizer or sunscreen is needed during the study, participants must
             be willing to use only allowed cleansers, moisturizers, sunscreens, or
             moisturizer/sunscreen combination products. If the participant wears makeup they must
             agree to use non-comedogenic makeup.

        Key Exclusion Criteria:

          -  Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study.

          -  Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gramnegative folliculitis.

          -  Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          -  Participants with a facial beard or mustache that could interfere with the study
             assessments.

          -  History of hypersensitivity or allergic reactions to any of the study preparations as
             described in the Investigator's Brochure, including known sensitivities to any dosage
             form of tretinoin.

          -  Participants who are unable to communicate or cooperate with the Investigator due to
             language problems, poor mental development, or impaired cerebral function.

          -  Participants with any underlying disease that the Investigator deems uncontrolled, and
             poses a concern for the participant's safety while participating in the study.