A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the
skin leaving it nicely moisturized allowing patients to move on with daily routines. In this
trial, the MC2-01 cream will be compared to a marketed calcipotriene [CAL]/betamethasone
dipropionate [BDP] ointment. The purpose of the trial, is to determine the pharmacokinetic
parameters of MC2-01 cream and the comparator under maximum use conditions.

Inclusion Criteria:

- Have provided written informed consent.

- Generally healthy males or non-pregnant females, of any race or ethnicity, who are at
least 18 years of age at the time of screening.

- At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris)
of at least 6 months duration involving scalp and body (trunk and/or limbs) that is
amenable to topical treatment with a maximum of 100 g of trial medication per week.

- Have a Physician's Global Assessment [PGA] of severity of at least moderate on the
trunk, limbs and/or scalp, at Visit 1/Day 0.

- Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk,
limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and
intertriginous areas, at Visit 1/Day 0.

Exclusion Criteria:

- Current diagnosis of unstable forms of psoriasis

- Other inflammatory skin disease in the treatment area

- Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas

- Planned exposure to natural or artificial sunlight

- Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and
during the trial;

- Current or past history of hypercalcemia, vitamin D toxicity, severe renal
insufficiency, or severe hepatic disorders;

- Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within
4 weeks prior to Visit 1/Day 0 during the trial period.

- Planned initiation of, or changes to concomitant medication that could affect calcium
metabolism during the trial;

- Planned initiation of, or changes to, concomitant estrogen therapy during the trial;

- Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist
1/Day 0 and during the trial period;

- Use of topical treatments, except for emollients and non-medicated shampoos, with a
possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the
trial period;

- Systemic treatment with biological therapies

- Initiation of, or expected changes to, concomitant medication that may affect
psoriasis during the trial period;

- Depression and endocrine disorders known to affect cortisol levels or HPA axis
integrity, non-nocturnal sleep patterns

- Systemic medication that suppresses the immune system within 4 weeks prior to the
Visit 1/Day 0 and during the trial period;

- Clinical signs of skin infection with bacteria, viruses, or fungi;

- Known human immunodeficiency virus [HIV] infection;

- Known or suspected of hypersensitivity to any component of the test product or
reference product;

- Any chronic or acute medical condition that may pose a risk to the safety of the
subject, or may interfere with the assessment of safety or efficacy in this trial;