A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris

A single-center, randomized, open-label, phase 1, comparative bioavailability study in
subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled
and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac
Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper
back, and shoulders. Following the baseline visit, subjects will return to the study center
daily for study product application. Blood samples to determine plasma concentrations of
tazarotenic acid will be collected before study product application on days 1, 8, 12, 15,
18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22
through 25.

Inclusion Criteria:

- Male or female 12 years of age or older who is in good general health.

- Have an Investigator's Static Global Assessment (ISGA) score of 3 or greater at
baseline. The area considered for the ISGA must be confined to the face.

- Regular menstrual cycle prior to study entry (as reported by the subject) for females
of childbearing potential.

- Negative urine pregnancy test for females of childbearing potential. • Sexually
active females of childbearing potential participating in the study must agree to use
a medically acceptable method of contraception while receiving protocol-assigned
product. A woman of childbearing potential is defined as one who is biologically
capable of becoming pregnant; including perimenopausal women who are less than 2
years from their last menses.

Women who are not currently sexually active must agree to use medically accepted methods
of contraception should they become sexually active while participating in the study. Male
subjects and/or their partners must use a medically acceptable form of contraception.

- Nonsmoker or smoker with at least 30 days abstinence from smoking or using
nicotine-containing products prior to study entry and willing not to smoke or to use
nicotine-containing products throughout the study.

- Ability and willingness to follow all study procedures, attend all scheduled visits,
and successfully complete the study.

- Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol specific procedures are performed

Exclusion Criteria:

- Female who is pregnant, trying to become pregnant, or breast feeding.

- History of known or suspected intolerance to any of the ingredients of the study
products.

- Use of topical antibiotics or topical corticosteroids for acne treatment within the
past 2 weeks.

- Use of systemic corticosteroids within the past 4 weeks.

- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.

- Concurrent use of medications known to be photosensitizers because of the possibility
of augmented photosensitivity.

- Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids) within the
past 2 weeks.

- Concomitant use of of facial products such as: abradants, facials, peels containing
glycolic or other acids .

- Facial procedure (eg, chemical or laser peel or microdermabrasion) performed by an
esthetician, beautician, physician, nurse, or other practitioner within the past 2
weeks.

- History or evidence of skin conditions other than acne (eg, eczema) that would
interfere with the subject's participation in the study.

- Consumption of alcohol within 24 hours prior to study product application on days 8,
12, 15, 18, 20, and 22 and within 72 hours post application on day 22.

- Consumption of xanthine-containing beverages or products (eg, caffeinated coffee,
tea, over-the counter medication for cold symptoms) within 24 hours prior to study
product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours
post-application on day 22.

- Anticipated need to engage in activities or exercise that would cause profuse
sweating during the study.

- Anticipated need for surgery or hospitalization during the study.

- Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight
or tanning beds) during the study.

- Concurrent involvement in another investigational study or participation within 30
days prior to the start of this study.

- Any other condition that, in the judgment of the investigator, would put the subject
at unacceptable risk for participation in the study.

- Currently lives in the same household as currently enrolled subjects; is an employee
of Stiefel, an investigator, or a contract research organization involved in the
study; or is an immediate family member (eg, partner, offspring, parents) of an
employee involved in the study.