A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: MC2-01 cream; Cal/BDP combination; Cream vehicle
Intervention description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream; calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%; Vehicle Cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 794.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is a randomized, investigator-blind, multicentre, vehicle- and
      comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety
      and convenience of the MC2-01 cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6
             months duration that involves the trunk and/or limbs that is amenable to topical
             treatment with a maximum of 100 g of trial medication per week

          -  Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)

          -  An mPASI score of at least 2

          -  Have a treatment area involving 2- 30% of the body surface area (BSA)

        Exclusion Criteria:

          -  Current diagnosis of unstable forms of psoriasis

          -  Other inflammatory skin disease in the treatment area that may confound the evaluation
             of the psoriasis vulgaris

          -  Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the
             treatment areas

          -  Planned exposure to either natural or artificial sunlight

          -  History of hypersensitivity to any component of the test product or reference product

          -  Current or past history of hypercalcemia, vitamin D toxicity, severe renal
             insufficiency, or severe hepatic disorders

          -  Systemic treatment with biological therapies

          -  Use of systemic treatments that suppress the immune system and other systemic
             chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and
             during the trial

          -  Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;

          -  Use of topical treatments, except for emollients and non-medicated shampoos, with a
             possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline

          -  Clinical signs of skin infection with bacteria, viruses, or fungi

          -  Known Human Immunodeficiency Virus (HIV) infection

          -  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