Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study.
Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle foam and
all adverse events and concomitant medications will be recorded.

Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis
who have been started on commercial Otezla in the last 7 days will be randomized to study
treatment as outlined above.

Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be
continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated
for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur
as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at
each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There
will be standard medication/treatment and washout periods.

Inclusion Criteria:

I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female
subjects of childbearing potential must have a (-)UPT (urine pregnancy test) result at
within 7 days of the first dose of study drug and practice a reliable method of
contraception throughout the study;

A female is considered of childbearing potential unless she is:

- postmenopausal ≥ 5 years of age, without a uterus and/or both ovaries; or has been
surgically sterile for ≥ 6 moths.

Reliable methods of contraception are:

- hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drug
administration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomized
partner.

[Exception: Female subjects of CBP (child bearing potential) who are not sexually active
are not required to practice a reliable method of contraception and may be enrolled at the
Investigator's discretion provided they are counseled to remain sexually inactive for the
duration of the study and understand the risks involved in getting pregnant during the
study.] ii. Subjects with moderate plaque type psoriasis who have been started on
commercial Otezla within the last 10 days.

iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study
requirements and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential
and not practicing a reliable method of birth control, or male subjects planning a
pregnancy with their spouse or partner while in the study.

ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or
hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv.
Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the
opinion of the investigator).

v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of
psoriasis.

vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or
alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments
required by the protocol. ix. Current enrollment in another clinical study and treatment
with another experimental drug or approved therapy for experimental use within 30 days
prior to the Screening Visit.