a maximal use trial evaluating the pharmacokinetic profile of mc2-01 cream

Conditions: Psoriasis Vulgaris

Summary: this is a phase 2, randomised, open-label, parallel-group, multicentre trial in which mc2-01 cream and calcipotriene \[cal\]/betamethasone \[bdp\] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.

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.

Eligibility criteria:
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;