Safety and Efficacy of IDP-123 Lotion to Tazorac® Cream, in the Treatment of Acne Vulgaris

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Study to Compare the
Safety and Efficacy of IDP-123 Lotion to Tazorac® (tazarotene) Cream, 0.1%, in the Treatment
of Acne Vulgaris

Key Inclusion Criteria:

- Male or female at least 12 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).

- Women of childbearing potential and females that are pre-menses must be willing to
practice effective contraception for the duration of the study. (Effective
contraception is defined as stabilized on oral contraceptive for at least 3 months,
IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring,
injection, transdermal patch or abstinence.) Females on birth control pills must have
taken the same type pill for at least three months prior to entering the study and
must not change type during the study. Those who have used birth control pills in the
past must have discontinued usage at least three months prior to the start of the
study. Women who use birth control for acne control only should be excluded.

- Pre-menses females and women of childbearing potential must have a negative urine
pregnancy test at the screening and baseline visits.

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, dermatitis,
eczema.

- 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.

- Evidence or history of cosmetic-related acne.

- Subject has a history of experiencing significant burning or stinging when applying
any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their
face.