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

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group
Comparison Study Comparing the Efficacy and Safety of IDP-121 Lotion 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. Subjects 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 subject reaches age of consent during the study they should
be re-consented at the next study visit)

- Subjects must be willing to comply with study instructions and return to the clinic
for required visits. Subjects 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, Subjects must be
willing to use only allowed cleansers, moisturizers, sunscreens, or
moisturizer/sunscreen combination products. If the subject 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.

- Subjects 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.

- Subjects who are unable to communicate or cooperate with the Investigator due to
language problems, poor mental development, or impaired cerebral function.

- Subjects with any underlying disease that the Investigator deems uncontrolled, and
poses a concern for the subjects safety while participating in the study.