Absorption and Systematic Pharmacokinetics of IDP-123 Lotion in Comparison With Tazorac Cream

Randomized study evaluating the absorption and systematic pharmacokinetics of IDP-123 lotion
in comparison with Tazorac Cream in subjects with moderate to severe acne vulgaris under
maximal use conditions.

Key Inclusion Criteria:

- Male or female, at least 9 years of age (at least 12 years of age for Tazorac Cream).

- Verbal and written 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 the subject reaches age of consent during the study they
should be re-consented at the next study visit).

- Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
Severity assessment at the screening and baseline visit.

- Subjects with facial acne inflammatory lesion count no less than 20 but no more than
40.

- Subjects with facial acne non-inflammatory lesions count no less than 20 but no more
than 100.

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 conglobate, acne fulminans, secondary acne, perioral
dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
eczema.

- Any underlying disease 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.

- Subjects with more than 2 facial nodules.