A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,
Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne
Vulgaris

Inclusion Criteria:

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

2. 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).

3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.

4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count
no less than 20, but no more than 100.

5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count
no less than 30, but no more than 150.

6. Subjects with 2 or fewer facial nodules

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, gram negative 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 2 facial nodules.

6. Evidence or history of cosmetic-related acne.