Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color

Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This
condition occurs in different ethnic groups worldwide with varying prevalence.

There are notable differences in psoriasis presentation in skin of color groups. Black
patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker
plaques, more scaling, and greater body involvement as compared to white patients. The
resolution of psoriasis lesions in darker skin types is associated with a higher rate of
dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients
than the psoriasis itself. Further, several studies have shown that psoriasis is associated
with greater psychological impact and worse quality of life in non-whites with psoriasis
compared to whites.

Unique issues in skin of color populations make studies dedicated to darker skin types
essential for the treatment of psoriasis in these populations. This study will evaluate the
efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate
0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will
also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as
the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin
of color.

Inclusion Criteria:

- Provide written, signed and dated informed consent prior to initiating any
study-related activities.

- Male or female >18 years of age at the time of screening

- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited
to - --African Americans, Asians, Pacific Islanders and Hispanics.

- Clinical diagnosis of chronic plaque-type psoriasis of the body

- Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp
involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of
0-4)

- Females of childbearing potential (FCBP) must have a negative pregnancy test at
Screening and Baseline. While using investigational product and for at least 28 days
after last application of investigational product, FCBP who engage in activity in
which conception is possible must use one of the approved contraceptive options d

- Must be in general good health as judged by the Investigator, based on medical history
and physical examination.

Exclusion Criteria:

- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate,
erythrodermic, pustular)

- Diagnosis of other active, ongoing skin diseases or skin infections that may interfere
with examination of psoriasis lesions

- Ongoing use of other psoriasis treatment including but not limited to topical or
systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic
medications for the treatment of psoriasis, and UV therapy. The following washout
periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12
weeks for biologic or targeted therapies; 4 weeks for other systemic therapies

- Use of oral estrogen therapy, excluding oral contraceptive pills

- Women who are pregnant, nursing, or of child-bearing potential who are unwilling to
use appropriate method(s) of contraception.

- Patients unwilling to limit exposure to UV light

- Current significant medical problems that, in the discretion of the investigator,
would put the patient at significant risk

- Patients with disorders of calcium metabolism and/or hypercalcemia

- Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)

- History of allergy to any component of the IP