Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-126 Gel in Comparison With Control Gel

To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in
IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne
vulgaris (acne) during once daily topical application of IDP-126 Gel for 28 days.

Inclusion Criteria:

1. Male or female, at least 9 years of age (at least 12 years of age for Control Gel);

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

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

Exclusion Criteria:

1. Use of an investigational drug or device within 30 days of enrollment or participation
in a research study concurrent with this study;

2. 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, dermatitis,
eczema;

3. 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;

4. Subjects with a facial beard or mustache that could interfere with the study
assessments;

5. Subjects with more than two (2) facial nodules;

6. Evidence or history of cosmetic-related acne