DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

This was a 15-day, randomized, multicenter, comparator-controlled, open-label study.
Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to
treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products
were applied twice daily for 15 days to all affected areas on the body excluding face, scalp,
groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening,
Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical
determinations of disease severity were conducted using the Investigator's Global Assessment
(IGA) for overall severity at each visit.

Inclusion Criteria:

Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
psoriasis.

Subjects with psoriasis involving 20 to 50% Body Surface Area (BSA), not including the
face, scalp, groin, axillae and other intertriginous areas.

Subjects must have an IGA grade of at least 3 (moderate) at the Baseline Visit Subjects
whose results from the screening Adrenocorticotropic hormone (ACTH) stimulation test are
considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no
other signs of abnormal HPA function or adrenal response

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
exfoliative or pustular psoriasis.

History of organ transplant requiring immunosuppression, HIV, or other immunocompromised
state.

Have received treatment for any type of cancer within 5 years of the Baseline Visit except
skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the
Baseline Visit.

Use within 60 days prior to the baseline Visit of: 1) immunosuppressive drugs (e.g.,
tacrolimus, pimecrolimus), or 2) systemic antipsoriatic treatment (e.g., methotrexate,
cyclosporine, hydroxyurea) Use within 30 days prior to the Baseline Visit of: 1) topical
antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) psoralen and
ultraviolet A (PUVA) therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate
mofetil, sulfasalazine, 6-thioguanine), or 4) ultraviolet B (UVB) therapy.

Use within 30 days prior to the Screening Visit of any product containing corticosteroids.
Inhaled, intraocular, intranasal, etc. steroids are not allowed.

Subjects who have an abnormal sleep schedule or work at night. Subjects with a known
history of acute adrenal crisis, Addison's disease or decreased adrenal output, low
pituitary function or pituitary tumors.

Subjects who have a history of an adverse reaction to cosyntropin injection or similar test
reagents.