A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: MC2-01 Cream; CAL/BDP combination
Intervention description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%); Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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;